Vegan DietNCT06669819
Influencing a Vegan Diet and the Intake of Dietary Supplements During Pregnancy and Childhood
An observational study of Vegan Diet and Pregnancy, run by Wolfgang Huber-Schneider at 1 site in Austria.
Trial summary
The main goals of the exploratory, cross-sectional survey among vegans are to reveal influencing factors, sources of information gathering, reasons for choosing certain dietary supplements of pregnant vegans and parents, difficulties in administering dietary supplements to children, and the compliance of dietary… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vegan Diet, Pregnancy, Dietary Supplements
- How many people
- 1,000 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Planned sample size for surveyed vegans: About 0.5-1% of the Austrian population follows a vegan diet (estimated - currently no exact numbers exist - source: vegan society Austria). In 2022, 82,198 children were born in Austria (Statistik Austria). In 5 years, around 400,000 children will be born in Austria - if 0.5-1% of them have parents that follow a vegan diet and are therefore also fed vegan, this results in an estimated number of 2000-4000 children and vegan parents. 25% of these should be reached with the survey. This corresponds to a planned sample size of 500-1000 vegans. Planned sample size for surveyed medical experts: Based on other scientific surveys in which physicians were included, we aim for 50-60 participants per expert group (paediatricians, gynaecologists, general practitioners, pharmacists, dieticians) for the questionnaire (see references: Vilette et al, 2022; Bardheci et al, 2021; Hamiel et al, 2020).
Who may be able to join
- For vegans:
- Females/gender-diverse participants (ages 18 and over) who follow/followed a vegan diet during their pregnancy/pregnancies (If there is/was more than one pregnancy, at least during one of their pregnancies)
- Parents (females/males/gender-diverse - ages 18 and over) who feed/fed their child/children (If there is more than one child, at least one of them) a vegan diet within the age of 0-5 years
- Vegan mothers/gender-diverse participants (ages 18 and over) who breastfeed/breastfed their infant(s)/child(ren). Answering questions regarding their infant(s)/child(ren) up to an age of 5 years will be included
- Pregnant and breastfeeding women/gender diverse participants/parents (f/m/d) who make rare exceptions to their vegan diet and a vegan diet of their child(ren) - up to an age of 5 years. Inclusion in the survey depends on the frequency of exceptions → determined through questions/given answers within the survey. Participants that consume animal products maximum twice a month will be included - hence participants who do not make vegetarian or pescetarian exceptions more than twice a month will be included 5.Confirmation of the consent form and participant information ( online - addressing the subjects, purpose and process of the study, opportunities for discussion of further questions, duration of the questionnaire, who is conducting the study, possibility for further inquiries)
- For medical experts:
- Gynaecologists, paediatricians, general practitioners, pharmacists, dieticians with or without a consulting focus on vegans
- Confirmation of the participant information/written consent
Who cannot join
- For vegans:
- Females/gender-diverse participants who change/changed their vegan diet (eat/ate a vegetarian or omnivorous diet) during their pregnancy/pregnancies
- Parents who do not feed/have never fed their children a vegan diet at least up to an age of 5 years (If vegan mothers followed a vegan diet during their pregnancy, exclusion only relates to questions concerning their children)
- No confirmation of the consent form and participant information (online) For the inclusion into the study at least one inclusion criteria (plus participant information) must be fulfilled. Exclusion (or not inclusion) will happen if only exclusion 3 is fulfilled. If only 1 or 2 is fulfilled - and 3 is not, participants will be included in the survey. All criteria will be proven by the study physician.
- For medical experts:
- Other medical specialists than mentioned in inclusion criteria
- No confirmation of the participant information/no written consent For the inclusion into the study all criteria must be fulfilled. Exclusion (or not inclusion) will happen if only one exclusion criteria is fulfilled. All criteria will be proven by the study physician.
- All participants have do understand the German language in order to answer the questionnaire.
Trial locations and contacts
1 site in 1 country.
Karl-Heinz Wagner contact
Austria1 site, 1 recruiting
- Recruiting
University of Vienna - Department of Nutritional Sciences
Vienna, Austria, 1090
Wolfgang Huber-Schneider, 00436767773179, a0225229@unet.univie.ac.at
Wolfgang Huber-Schneider
About this study
Official title: Can Dietary Supplements be Linked to a Vegan Diet and Health Risk Modulation During Vegan Pregnancy, Infancy and Early Childhood
The main goals of the exploratory, cross-sectional survey among vegans are to reveal influencing factors, sources of information gathering, reasons for choosing certain dietary supplements of pregnant vegans and parents, difficulties in administering dietary supplements to children, and the compliance of dietary supplements of vegans, because there is no data available yet. Results serve as a starting point for comprehensive information provision for surveyed vegans and provide insight into the nutritional knowledge of vegans. The advisory role of the medical experts is essential to provide vegans with reliable information on a balanced vegan diet and dietary supplements. The opinion of medical experts has a decisive influence on the health of vegans. For this reason the content of their advice will be assessed.
The main questions the study aims to answer are: Do vegan pregnant women and parents know about possible nutrient deficiencies during pregnancy and childhood and who do they turn to for information about nutritional supplements? What is the quality of the information received?
Read the detailed description
During intensive development phases, such as pregnancy and childhood, the probability of insufficient nutrient supply raises. In the course of a vegan diet, the focus should be on an adequate supply of vitamin B12, zinc, iron, calcium, vitamin D, iodide, omega-3 fatty acids and iron. Nutrient deficiency can be prevented by supplying these critical nutrients of a vegan diet adequately. A purely plant-based diet can provide all necessary macro- and micronutrients during pregnancy and childhood, except DHA and EPA, as well as vitamin B12. Newborns of vegan mothers are smaller (small for gestational age) and are born with a lower birth weight than those born from omnivores, which can lead to further nutrient-deficiency-related development and health consequences. If the mother lacks an adequate supply of nutrients, nutrient deficiencies can occur in the infant despite breastfeeding. Expert groups such as the Academy of Nutrition and Dietetics (AND) and German Society for Nutrition (DGE) disagree about the risks of a purely plant-based diet for pregnant women, infants and children. In the past no distinct statements were made on the benefits or drawbacks for vegan pregnant women and their children in terms of nutrient supply, due to a lack of well-designed studies. Latest findings show that there are risks of malnutrition, which can be prevented by dietary supplements and observing the health and developmental status of mother and child. Although the selection of vegan foods is becoming more diverse, there is no data on whether this expansion of the offer results in a better nutrient supply for vegans - the current state of studies suggests dietary supplementation is necessary. Pregnant women who consume an omnivorous diet are often taking dietary supplements to support the healthy development of their unborn children. Influencing factors that affect the approach of vegan pregnant women and parents towards dietary supplements have not yet been scientifically determined. It has been shown that mothers who feed their children a vegan diet have less nutritional knowledge than mothers whose children follow an ovo-lacto-vegetarian diet. Parents often ask pediatricians how to provide the most balanced diet for their children. For this reason, constructive communication between parents of vegan children and their pediatricians and dieticians is important in order to provide comprehensive information about a healthy, purely plant-based diet. The relationship between vegan parents and doctors can therefore influence the health and well-being of vegan children. However, the majority of pediatricians is perceived skeptical or negative towards a vegan diet, which can affect vegan parents' trust in their children's doctors and limit or prevent communication. Many parents don't inform pediatricians about their children's vegan diet in order not to be exposed to criticism. The skeptical attitude of doctors could result from legitimate, nutrition-related objections on the one hand and from a lack of knowledge about a vegan diet and dietary supplements on the other. This can lead to health consequences for vegan pregnant women and children due to a lack of information supply and miscommunication. It is not yet clear whether other specialists and medical experts in addition to pediatricians have a negative attitude towards a vegan diet during pregnancy and childhood and therefore offer little or no advice on vegan diets and dietary supplements. If a negative attitude also exists among gynecologists, general practitioners, dieticians and pharmacists, this could have a negative effect on vegans due to a lack of information transfer. The level of information and the associated information provided by medical experts on a vegan diet and dietary supplements during pregnancy and childhood therefore has a significant impact on the adequate nutrient supply of metioned vegans. The level of knowledge among medical experts regarding a vegan diet and dietary supplements has not yet been sufficiently examined. Competent advice on supplementation with dietary supplements is essential for a healthy development during pregnancy and childhood. If information is not provided by medical experts, vegans use other sources of information. It can be assumed that many vegans are insufficiently, incorrectly or not at all informed about dietary supplements and a well-balanced vegan diet due to the different quality of provided information. Dubious sources of information and external influencing factors (social environment, Internet and Social Media, magazines, advertisement etc.) are likely to make parents feel insecure and can affect the health of their children. A lack of expertise on the part of vegan pregnant women and parents (on a vegan diet and dietary supplements) and insufficient support from medical experts (paediatricians, gynaecologists, general practitioners, pharmacists, dieticians) entails possible health risks. The impact of medical expertise and other social, sociodemographic factors (age, social environment and background, Internet and Social Media, advertising etc.), on the diet of vegan pregnant women and children (up to an age of 5 years), as well as on supplementation with dietary supplements needs to be researched. Whether and to what extent external factors influence a vegan pregnancy, infancy and childhood has not yet been scientifically investigated. In addition, there is still no data on the opinion and level of knowledge of consulting medical experts and associated consequences regarding nutrition and the possibility of supplementing dietary supplements for vegans. Results may demonstrate the need for comprehensive counseling on dietary supplements and a vegan diet and highlight the need for better and competent information provision by medical experts to pregnant vegan women and parents of vegan children.
- Conditions
- Vegan Diet, Pregnancy, Dietary Supplements, Childhood
- Keywords
- vegan, pregnancy, pregnant, childhood, dietary supplements, parents, medical experts, paediatrician, gynaecologist, general practitioner, pharmacist, dietician
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| vegan pregnant women and vegan parents | Not described | |
| medical experts | paediatricians, gynaecologists, general practitioners, pharmacists, dieticians |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of main influencing factors that affect vegans regarding their diet during pregnancy and when feeding their vegan children (up to an age of 5 years)
Influence by medical experts or other influences (social environment, Internet and Social Media, magazines etc.) concerning the decision for or against a vegan diet should be clarified. Depending on the source of information, possible risks of a vegan diet during pregnancy, infancy and early childhood can be misjudged.
Measured: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
Identify sources of information for vegans on dietary supplements, as a reason for approval or rejection of dietary supplements (during pregnancy, infancy and early childhood) - trustworthiness by ranking
It should be determined which information on dietary supplements (during pregnancy, infancy and early childhood) is used and whether this information appears trustworthy or causes uncertainty. Information received affects selection, intake, or avoidance of certain dietary supplements. The health impact of selected sources of information on dietary supplements can be made visible. Medical expert advice and other opinion-forming aspects (social environment, Internet and Social Media, magazines etc.) should be ranked according to their relevance. The main source of information should be identified. This can be an important approach for the improvement of information supply on dietary supplements in the vegan diet and for minimizing risks preventively. By recognizing the source of information that is classified as the most important for vegans, the main causes of frequent inadequacies in the supply of information can be identified and positively changed.
Measured: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
Viewpoints and general knowledge of medical experts about a vegan diet and dietary supplements (for a vegan pregnancy, infancy and early childhood) should be established
The impact of expert opinion and knowledge on the vegan diet regarding their advice on dietary supplements for vegans (during vegan pregnancy, infancy and early childhood) should be clarified. Statistically evaluated results of the survey should allow conclusions about the influence of information supply by medical experts on nutrient supply, of vegan pregnant women and growing children (up to an age of 5 years). A possible misinterpretation of the health risk of a vegan diet during pregnancy, infancy and early childhood due to insufficient knowledge of dietary supplements could increase health risks. A negative basic attitude towards a vegan diet influences the relationship of trust between vegans and their physicians. If there is no advice on dietary supplements, health risks can increase.
Measured: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
Secondary outcomes (3)
Determination of the level of knowledge of vegans on dietary supplements, nutrient deficiency risks and incorrect dosing of dietary supplements during pregnancy, infancy and early childhood (up to an age of 5 years)
If the risk of incorrect dosing of dietary supplements is misjudged by vegans during pregnancy, infancy and early childhood, nutrient deficiencies or overdose with dietary supplements become likely. Risks of a nutrient deficiency due to missing intake or incorrect selection of dietary supplements because of a lack of knowledge should also be cognizable. Avoiding these circumstances would require a better supply of information for vegans by medical experts (paediatricians, gynaecologists, general practitioners, pharmacists, dieticians). If the risk of incorrect dosing is misjudged by medical experts the quality of advice on dietary supplements could suffer. Imprecise advice could affect the relationship of trust between medical experts and vegans as well as the nutrient supply during pregnancy, infancy and early childhood.
Measured: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
Definition and effectiveness as well as health and health optimization through dietary supplements from a vegan perspective
The perception of what a dietary supplement can do, whether it is comparable to medicine or food, or whether a positive/negative effect can be expected, depends on the level of knowledge of vegans about dietary supplements. How vegans perceive dietary supplements and how they rate their effectiveness influences their intake behavior. What health means for vegans and whether dietary supplements are perceived as health-promoting from a vegan perspective should also be clarified. Determining what is meant by health optimization for vegans creates an understanding of the intake or rejection of dietary supplements. Rejection of dietary supplementsdue to health concerns can indicate insufficient education about health benefits.
Measured: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
Determination of compliance with dietary supplements (DS) during pregnancy, infancy and early childhood as well as the consequences of administration difficulties to vegan children (up to an age of 5 years)
It should be investigated whether vegans consider regular intake or administration of DS during pregnancy and early childhood to be effective. It should be clarified whether dosage forms (e.g. drops, pills, capsules etc.) of existing DS for infants and children represent an unsettling factor for the vegan parents, which in turn increases the risk of incorrect dosing and resulting nutrient deficiencies (wrong administration, wrong dosing etc.). Medical experts should also evaluate the options of dosage forms and the compliance as well as the consistency of administration by parents to the vegan child. This should clarify whether dosage forms of DS can have an impact on the regularity of administration and subsequently on the development of nutrient deficiencies. Statements about the regularity, duration of intake and compliance of DS are intended to allow conclusions about the supply of consumers with the corresponding DS and to show any potential dangers or health-enhancing effects.
Measured: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Oct 2023
- Primary completion31 Jul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Vegan DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfgang Huber-Schneider
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vienna, Austrian Agency for Health and Food Safety GmbH - AGES
- Responsible party
- Sponsor-investigator, Wolfgang Huber-Schneider, University of Vienna
- Investigators
- Wolfgang Huber-Schneider, Principal investigator, University of ViennaKarl-Heinz Wagner, Study director, University of ViennaIngrid Kiefer, Study director, Austrian Agency for Health and Food Safety GmbH - AGES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669819
- Sponsor's protocol ID
- VedieS
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amit M. Vegetarian diets in children and adolescents. Paediatr Child Health. 2010 May;15(5):303-14.
PubMed 21532796Avnon T, Paz Dubinsky E, Lavie I, Ben-Mayor Bashi T, Anbar R, Yogev Y. The impact of a vegan diet on pregnancy outcomes. J Perinatol. 2021 May;41(5):1129-1133. doi: 10.1038/s41372-020-00804-x. Epub 2020 Sep 1.
PubMed 32873905Baldassarre ME, Panza R, Farella I, Posa D, Capozza M, Mauro AD, Laforgia N. Vegetarian and Vegan Weaning of the Infant: How Common and How Evidence-Based? A Population-Based Survey and Narrative Review. Int J Environ Res Public Health. 2020 Jul 5;17(13):4835. doi: 10.3390/ijerph17134835.
PubMed 32635592Bardheci K, Jager L, Risch L, Rosemann T, Burgstaller JM, Markun S. Testing and Prescribing Vitamin B12 in Swiss General Practice: A Survey among Physicians. Nutrients. 2021 Jul 29;13(8):2610. doi: 10.3390/nu13082610.
PubMed 34444770Baroni L, Goggi S, Battaglino R, Berveglieri M, Fasan I, Filippin D, Griffith P, Rizzo G, Tomasini C, Tosatti MA, Battino MA. Vegan Nutrition for Mothers and Children: Practical Tools for Healthcare Providers. Nutrients. 2018 Dec 20;11(1):5. doi: 10.3390/nu11010005.
PubMed 30577451Bivi D, Di Chio T, Geri F, Morganti R, Goggi S, Baroni L, Mumolo MG, de Bortoli N, Peroni DG, Marchi S, Bellini M. Raising Children on a Vegan Diet: Parents' Opinion on Problems in Everyday Life. Nutrients. 2021 May 25;13(6):1796. doi: 10.3390/nu13061796.
PubMed 34070399Brown B, Wright C. Safety and efficacy of supplements in pregnancy. Nutr Rev. 2020 Oct 1;78(10):813-826. doi: 10.1093/nutrit/nuz101.
PubMed 31925443Chouraqui JP. Risk Assessment of Micronutrients Deficiency in Vegetarian or Vegan Children: Not So Obvious. Nutrients. 2023 Apr 28;15(9):2129. doi: 10.3390/nu15092129.
PubMed 37432244Hamiel U, Landau N, Eshel Fuhrer A, Shalem T, Goldman M. The Knowledge and Attitudes of Pediatricians in Israel Towards Vegetarianism. J Pediatr Gastroenterol Nutr. 2020 Jul;71(1):119-124. doi: 10.1097/MPG.0000000000002721.
PubMed 32304543Hay G, Fadnes L, Meltzer HM, Arnesen EK, Henriksen C. Follow-up of pregnant women, breastfeeding mothers and infants on a vegetarian or vegan diet. Tidsskr Nor Laegeforen. 2022 Apr 27;142(7). doi: 10.4045/tidsskr.21.0847. Print 2022 May 3. No abstract available. English, Norwegian.
PubMed 35510463Hovinen T, Korkalo L, Freese R, Skaffari E, Isohanni P, Niemi M, Nevalainen J, Gylling H, Zamboni N, Erkkola M, Suomalainen A. Vegan diet in young children remodels metabolism and challenges the statuses of essential nutrients. EMBO Mol Med. 2021 Feb 5;13(2):e13492. doi: 10.15252/emmm.202013492. Epub 2021 Jan 20.
PubMed 33471422Koebnick C, Hoffmann I, Dagnelie PC, Heins UA, Wickramasinghe SN, Ratnayaka ID, Gruendel S, Lindemans J, Leitzmann C. Long-term ovo-lacto vegetarian diet impairs vitamin B-12 status in pregnant women. J Nutr. 2004 Dec;134(12):3319-26. doi: 10.1093/jn/134.12.3319.
PubMed 15570032Kiely ME. Risks and benefits of vegan and vegetarian diets in children. Proc Nutr Soc. 2021 May;80(2):159-164. doi: 10.1017/S002966512100001X. Epub 2021 Jan 28.
PubMed 33504371Kostecka M, Kostecka J, Jackowska I, Ilowiecka K. Parental Nutritional Knowledge and Type of Diet as the Key Factors Influencing the Safety of Vegetarian Diets for Children Aged 12-36 Months. Nutrients. 2023 May 9;15(10):2244. doi: 10.3390/nu15102244.
PubMed 37242126Lemale J, Mas E, Jung C, Bellaiche M, Tounian P; French-speaking Pediatric Hepatology, Gastroenterology and Nutrition Group (GFHGNP). Vegan diet in children and adolescents. Recommendations from the French-speaking Pediatric Hepatology, Gastroenterology and Nutrition Group (GFHGNP). Arch Pediatr. 2019 Oct;26(7):442-450. doi: 10.1016/j.arcped.2019.09.001. Epub 2019 Oct 12.
PubMed 31615715
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Dietary Supplements be Linked to a Vegan Diet and Health Risk Modulation During Vegan Pregnancy, Infancy and Early Childhood
- ClinicalTrials.gov ID
- NCT06669819
- Acronym / sponsor ID
- VedieS
- Conditions
- Vegan Diet, Pregnancy, Dietary Supplements, Childhood
- Keywords
- vegan, pregnancy, pregnant, childhood, dietary supplements, parents, medical experts, paediatrician
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Wolfgang Huber-SchneiderUniversity, hospital or other
- Collaborators
- University of Vienna, Austrian Agency for Health and Food Safety GmbH - AGES
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goals of the exploratory, cross-sectional survey among vegans are to reveal influencing factors, sources of information gathering, reasons for choosing certain dietary supplements of pregnant vegans and parents, difficulties in administering dietary supplements to children, and the compliance of dietary supplements of vegans, because there is no data available yet. Results serve as a starting point for comprehensive information provision for surveyed vegans and provide insight into the nutritional knowledge of vegans. The advisory role of the medical experts is essential to provide vegans with reliable information on a balanced vegan diet and dietary supplements. The opinion of medical experts has a decisive influence on the health of vegans. For this reason the content of their advice will be assessed.
The main questions the study aims to answer are: Do vegan pregnant women and parents know about possible nutrient deficiencies during pregnancy and childhood and who do they turn to for information about nutritional supplements? What is the quality of the information received?
Detailed description
During intensive development phases, such as pregnancy and childhood, the probability of insufficient nutrient supply raises. In the course of a vegan diet, the focus should be on an adequate supply of vitamin B12, zinc, iron, calcium, vitamin D, iodide, omega-3 fatty acids and iron. Nutrient deficiency can be prevented by supplying these critical nutrients of a vegan diet adequately. A purely plant-based diet can provide all necessary macro- and micronutrients during pregnancy and childhood, except DHA and EPA, as well as vitamin B12. Newborns of vegan mothers are smaller (small for gestational age) and are born with a lower birth weight than those born from omnivores, which can lead to further nutrient-deficiency-related development and health consequences. If the mother lacks an adequate supply of nutrients, nutrient deficiencies can occur in the infant despite breastfeeding. Expert groups such as the Academy of Nutrition and Dietetics (AND) and German Society for Nutrition (DGE) disagree about the risks of a purely plant-based diet for pregnant women, infants and children. In the past no distinct statements were made on the benefits or drawbacks for vegan pregnant women and their children in terms of nutrient supply, due to a lack of well-designed studies. Latest findings show that there are risks of malnutrition, which can be prevented by dietary supplements and observing the health and developmental status of mother and child. Although the selection of vegan foods is becoming more diverse, there is no data on whether this expansion of the offer results in a better nutrient supply for vegans - the current state of studies suggests dietary supplementation is necessary. Pregnant women who consume an omnivorous diet are often taking dietary supplements to support the healthy development of their unborn children. Influencing factors that affect the approach of vegan pregnant women and parents towards dietary supplements have not yet been scientifically determined. It has been shown that mothers who feed their children a vegan diet have less nutritional knowledge than mothers whose children follow an ovo-lacto-vegetarian diet. Parents often ask pediatricians how to provide the most balanced diet for their children. For this reason, constructive communication between parents of vegan children and their pediatricians and dieticians is important in order to provide comprehensive information about a healthy, purely plant-based diet. The relationship between vegan parents and doctors can therefore influence the health and well-being of vegan children. However, the majority of pediatricians is perceived skeptical or negative towards a vegan diet, which can affect vegan parents' trust in their children's doctors and limit or prevent communication. Many parents don't inform pediatricians about their children's vegan diet in order not to be exposed to criticism. The skeptical attitude of doctors could result from legitimate, nutrition-related objections on the one hand and from a lack of knowledge about a vegan diet and dietary supplements on the other. This can lead to health consequences for vegan pregnant women and children due to a lack of information supply and miscommunication. It is not yet clear whether other specialists and medical experts in addition to pediatricians have a negative attitude towards a vegan diet during pregnancy and childhood and therefore offer little or no advice on vegan diets and dietary supplements. If a negative attitude also exists among gynecologists, general practitioners, dieticians and pharmacists, this could have a negative effect on vegans due to a lack of information transfer. The level of information and the associated information provided by medical experts on a vegan diet and dietary supplements during pregnancy and childhood therefore has a significant impact on the adequate nutrient supply of metioned vegans. The level of knowledge among medical experts regarding a vegan diet and dietary supplements has not yet been sufficiently examined. Competent advice on supplementation with dietary supplements is essential for a healthy development during pregnancy and childhood. If information is not provided by medical experts, vegans use other sources of information. It can be assumed that many vegans are insufficiently, incorrectly or not at all informed about dietary supplements and a well-balanced vegan diet due to the different quality of provided information. Dubious sources of information and external influencing factors (social environment, Internet and Social Media, magazines, advertisement etc.) are likely to make parents feel insecure and can affect the health of their children. A lack of expertise on the part of vegan pregnant women and parents (on a vegan diet and dietary supplements) and insufficient support from medical experts (paediatricians, gynaecologists, general practitioners, pharmacists, dieticians) entails possible health risks. The impact of medical expertise and other social, sociodemographic factors (age, social environment and background, Internet and Social Media, advertising etc.), on the diet of vegan pregnant women and children (up to an age of 5 years), as well as on supplementation with dietary supplements needs to be researched. Whether and to what extent external factors influence a vegan pregnancy, infancy and childhood has not yet been scientifically investigated. In addition, there is still no data on the opinion and level of knowledge of consulting medical experts and associated consequences regarding nutrition and the possibility of supplementing dietary supplements for vegans. Results may demonstrate the need for comprehensive counseling on dietary supplements and a vegan diet and highlight the need for better and competent information provision by medical experts to pregnant vegan women and parents of vegan children.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vegan pregnant women and vegan parents | – | – |
| medical experts | – | –paediatricians, gynaecologists, general practitioners, pharmacists, dieticians |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Planned sample size for surveyed vegans: About 0.5-1% of the Austrian population follows a vegan diet (estimated - currently no exact numbers exist - source: vegan society Austria). In 2022, 82,198 children were born in Austria (Statistik Austria). In 5 years, around 400,000 children will be born in Austria - if 0.5-1% of them have parents that follow a vegan diet and are therefore also fed vegan, this results in an estimated number of 2000-4000 children and vegan parents. 25% of these should be reached with the survey. This corresponds to a planned sample size of 500-1000 vegans. Planned sample size for surveyed medical experts: Based on other scientific surveys in which physicians were included, we aim for 50-60 participants per expert group (paediatricians, gynaecologists, general practitioners, pharmacists, dieticians) for the questionnaire (see references: Vilette et al, 2022; Bardheci et al, 2021; Hamiel et al, 2020).
Key inclusion criteria (8 listed)
- For vegans:
- Females/gender-diverse participants (ages 18 and over) who follow/followed a vegan diet during their pregnancy/pregnancies (If there is/was more than one pregnancy, at least during one of their pregnancies)
- Parents (females/males/gender-diverse - ages 18 and over) who feed/fed their child/children (If there is more than one child, at least one of them) a vegan diet within the age of 0-5 years
- Vegan mothers/gender-diverse participants (ages 18 and over) who breastfeed/breastfed their infant(s)/child(ren). Answering questions regarding their infant(s)/child(ren) up to an age of 5 years will be included
- Pregnant and breastfeeding women/gender diverse participants/parents (f/m/d) who make rare exceptions to their vegan diet and a vegan diet of their child(ren) - up to an age of 5 years. Inclusion in the survey depends on the frequency of exceptions → determined through questions/given answers within the survey. Participants that consume animal products maximum twice a month will be included - hence participants who do not make vegetarian or pescetarian exceptions more than twice a month will be included 5.Confirmation of the consent form and participant information ( online - addressing the subjects, purpose and process of the study, opportunities for discussion of further questions, duration of the questionnaire, who is conducting the study, possibility for further inquiries)
Key exclusion criteria (8 listed)
- For vegans:
- Females/gender-diverse participants who change/changed their vegan diet (eat/ate a vegetarian or omnivorous diet) during their pregnancy/pregnancies
- Parents who do not feed/have never fed their children a vegan diet at least up to an age of 5 years (If vegan mothers followed a vegan diet during their pregnancy, exclusion only relates to questions concerning their children)
- No confirmation of the consent form and participant information (online) For the inclusion into the study at least one inclusion criteria (plus participant information) must be fulfilled. Exclusion (or not inclusion) will happen if only exclusion 3 is fulfilled. If only 1 or 2 is fulfilled - and 3 is not, participants will be included in the survey. All criteria will be proven by the study physician.
- For medical experts:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of main influencing factors that affect vegans regarding their diet during pregnancy and when feeding their vegan children (up to an age of 5 years)
Time frame: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
Influence by medical experts or other influences (social environment, Internet and Social Media, magazines etc.) concerning the decision for or against a vegan diet should be clarified. Depending on the source of information, possible risks of a vegan diet during pregnancy, infancy and early childhood can be misjudged.
Identify sources of information for vegans on dietary supplements, as a reason for approval or rejection of dietary supplements (during pregnancy, infancy and early childhood) - trustworthiness by ranking
Time frame: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
It should be determined which information on dietary supplements (during pregnancy, infancy and early childhood) is used and whether this information appears trustworthy or causes uncertainty. Information received affects selection, intake, or avoidance of certain dietary supplements. The health impact of selected sources of information on dietary supplements can be made visible. Medical expert advice and other opinion-forming aspects (social environment, Internet and Social Media, magazines etc.) should be ranked according to their relevance. The main source of information should be identified. This can be an important approach for the improvement of information supply on dietary supplements in the vegan diet and for minimizing risks preventively. By recognizing the source of information that is classified as the most important for vegans, the main causes of frequent inadequacies in the supply of information can be identified and positively changed.
Viewpoints and general knowledge of medical experts about a vegan diet and dietary supplements (for a vegan pregnancy, infancy and early childhood) should be established
Time frame: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
The impact of expert opinion and knowledge on the vegan diet regarding their advice on dietary supplements for vegans (during vegan pregnancy, infancy and early childhood) should be clarified. Statistically evaluated results of the survey should allow conclusions about the influence of information supply by medical experts on nutrient supply, of vegan pregnant women and growing children (up to an age of 5 years). A possible misinterpretation of the health risk of a vegan diet during pregnancy, infancy and early childhood due to insufficient knowledge of dietary supplements could increase health risks. A negative basic attitude towards a vegan diet influences the relationship of trust between vegans and their physicians. If there is no advice on dietary supplements, health risks can increase.
3 secondary outcomes
Determination of the level of knowledge of vegans on dietary supplements, nutrient deficiency risks and incorrect dosing of dietary supplements during pregnancy, infancy and early childhood (up to an age of 5 years)
Time frame: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
Definition and effectiveness as well as health and health optimization through dietary supplements from a vegan perspective
Time frame: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
Determination of compliance with dietary supplements (DS) during pregnancy, infancy and early childhood as well as the consequences of administration difficulties to vegan children (up to an age of 5 years)
Time frame: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Background: PubMed 21532796Amit M. Vegetarian diets in children and adolescents. Paediatr Child Health. 2010 May;15(5):303-14.
- Background: PubMed 32873905Avnon T, Paz Dubinsky E, Lavie I, Ben-Mayor Bashi T, Anbar R, Yogev Y. The impact of a vegan diet on pregnancy outcomes. J Perinatol. 2021 May;41(5):1129-1133. doi: 10.1038/s41372-020-00804-x. Epub 2020 Sep 1.
- Background: PubMed 32635592Baldassarre ME, Panza R, Farella I, Posa D, Capozza M, Mauro AD, Laforgia N. Vegetarian and Vegan Weaning of the Infant: How Common and How Evidence-Based? A Population-Based Survey and Narrative Review. Int J Environ Res Public Health. 2020 Jul 5;17(13):4835. doi: 10.3390/ijerph17134835.
- Background: PubMed 34444770Bardheci K, Jager L, Risch L, Rosemann T, Burgstaller JM, Markun S. Testing and Prescribing Vitamin B12 in Swiss General Practice: A Survey among Physicians. Nutrients. 2021 Jul 29;13(8):2610. doi: 10.3390/nu13082610.
- Background: PubMed 30577451Baroni L, Goggi S, Battaglino R, Berveglieri M, Fasan I, Filippin D, Griffith P, Rizzo G, Tomasini C, Tosatti MA, Battino MA. Vegan Nutrition for Mothers and Children: Practical Tools for Healthcare Providers. Nutrients. 2018 Dec 20;11(1):5. doi: 10.3390/nu11010005.
- Background: PubMed 34070399Bivi D, Di Chio T, Geri F, Morganti R, Goggi S, Baroni L, Mumolo MG, de Bortoli N, Peroni DG, Marchi S, Bellini M. Raising Children on a Vegan Diet: Parents' Opinion on Problems in Everyday Life. Nutrients. 2021 May 25;13(6):1796. doi: 10.3390/nu13061796.
- Background: PubMed 31925443Brown B, Wright C. Safety and efficacy of supplements in pregnancy. Nutr Rev. 2020 Oct 1;78(10):813-826. doi: 10.1093/nutrit/nuz101.
- Background: PubMed 37432244Chouraqui JP. Risk Assessment of Micronutrients Deficiency in Vegetarian or Vegan Children: Not So Obvious. Nutrients. 2023 Apr 28;15(9):2129. doi: 10.3390/nu15092129.
- Background: PubMed 32304543Hamiel U, Landau N, Eshel Fuhrer A, Shalem T, Goldman M. The Knowledge and Attitudes of Pediatricians in Israel Towards Vegetarianism. J Pediatr Gastroenterol Nutr. 2020 Jul;71(1):119-124. doi: 10.1097/MPG.0000000000002721.
- Background: PubMed 35510463Hay G, Fadnes L, Meltzer HM, Arnesen EK, Henriksen C. Follow-up of pregnant women, breastfeeding mothers and infants on a vegetarian or vegan diet. Tidsskr Nor Laegeforen. 2022 Apr 27;142(7). doi: 10.4045/tidsskr.21.0847. Print 2022 May 3. No abstract available. English, Norwegian.
- Background: PubMed 33471422Hovinen T, Korkalo L, Freese R, Skaffari E, Isohanni P, Niemi M, Nevalainen J, Gylling H, Zamboni N, Erkkola M, Suomalainen A. Vegan diet in young children remodels metabolism and challenges the statuses of essential nutrients. EMBO Mol Med. 2021 Feb 5;13(2):e13492. doi: 10.15252/emmm.202013492. Epub 2021 Jan 20.
- Background: PubMed 15570032Koebnick C, Hoffmann I, Dagnelie PC, Heins UA, Wickramasinghe SN, Ratnayaka ID, Gruendel S, Lindemans J, Leitzmann C. Long-term ovo-lacto vegetarian diet impairs vitamin B-12 status in pregnant women. J Nutr. 2004 Dec;134(12):3319-26. doi: 10.1093/jn/134.12.3319.
- estimated number of vegans in Austria (vegan society Austria)Link provided by the sponsor.
- children born in Austria in 2023 (Statistik Austria)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl-Heinz Wagner contact
Wolfgang Huber-Schneider principal investigator
University of Vienna
Karl-Heinz Wagner study director
University of Vienna
Ingrid Kiefer study director
Austrian Agency for Health and Food Safety GmbH - AGES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vegan Diet and Pregnancy, run by Wolfgang Huber-Schneider at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wolfgang Huber-Schneider (00436767773179, a0225229@unet.univie.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of main influencing factors that affect vegans regarding their diet during pregnancy and when feeding their vegan children (up to an age of 5 years) (time frame: The assessment of the study will take place approximately 24 months after participation of vegans/medical experts in the survey). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06669819, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.