Vegan DietVHSNCT05442281
Vegan Diet in Small Children
An observational study of Vegan Diet, run by Umeå University at 1 site in Sweden.
Trial summary
Following increased knowledge about climate change and how food production affects greenhouse gas emissions, the interest in vegetarian diets is increasing. In line with this, also vegan diet is becoming more common at all ages, including in young children. Read more about this study
- Who is it for?
- Ages 4 to 8 monthsHealthy volunteers can take part
- Conditions the study is for
- Vegan Diet
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2021to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 4 to 8 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Swedish infants mainly breastfed planned for vegan or mixed diet respectively
Who may be able to join
- Planned exclusive vegan diet or mixed diet respectively from 6 months of age until at least 2 years of life
- Exclusively (>90%) breastfed until 4 months
- Born term (GE 37+0 - 41+6)
- Single birth
- Birth weight >2500 g
- Apgar score 5 min > 5
Who cannot join
- A chronic disease affecting growth or neurodevelopment
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Umeå University, Department of Clinical Sciences
Umeå, Umeå, 90185
About this study
Official title: Vegan Diet in Young Children - Studies of Nutritional Intake, Growth and Neurodevelopment
Following increased knowledge about climate change and how food production affects greenhouse gas emissions, the interest in vegetarian diets is increasing. In line with this, also vegan diet is becoming more common at all ages, including in young children. But the state of knowledge regarding the effect of this diet on children during infancy and early childhood has been poorly studied and existing literature consists to a large extent of case reports.
With the main hypothesis that vegan diet from the introduction of complementary foods causes reduced bio availability of certain micronutrients important for development, the aim of this study is to examine dietary intake and development during the first years of life in a group of children eating vegan diet and compare with a reference group eating mixed diets.
Read more
In an observational study, investigators plan to include 30 children before the age of 6 months during the years 2021-2026, where the parents have decided to offer their child only vegan food. The children are studied in comparison with a reference group of 30 matched cases regarding growth, nutritional status, and dietary intake. Data collection includes monthly dietary records and blood sample analyses and growth at 6, 12 and 24 months. At the age of 3, cognitive developmental assessment (WPSSI-IV) and an DEXA examination of body composition are performed.
The study is expected to contribute to increased knowledge about the risk and benefits of vegan diets and thereby provide a better basis for future recommendations.
- Conditions
- Vegan Diet
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 diet | Children fed vegan diet from 6 months of life | |
| Mixed diet | Children fed mixed diet from 6 months of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Hemoglobin
Blood
Measured: 12 months of age
Body Weight (kg)
measured weight at 12 mo using a device for measuring weight
Measured: 12 months of age
Secondary outcomes (18)
Wechsler Preschool & Primary Scale of Intelligence
Scale for cognitive development. Expected mean 100. Higher scores equals better cognitive development.
Measured: 3 years of age
Fat mass index
FMI, measured by DEXA-scan
Measured: 3 years of age
Lean mass index
LMI, measured by DEXA-scan
Measured: 3 years of age
Protein intake
3 day food diary
Measured: at 12 months of age
Fat intake
3 day food diary
Measured: at 12 months of age
Carbohydrate intake
3 day food diary
Measured: at 12 months of age
Iron intake (mg/day)
3 day food diary
Measured: throughout study
B12 levels
Serum sample
Measured: 6, 12, 24, 36 months
Zink level
Serum sample
Measured: 6, 12, 24, 36 months
D-vitamin levels
Serum sample
Measured: 6, 12, 24, 36 months
Calcium levels
Serum sample
Measured: 6, 12, 24, 36 months
Homocysteine levels
serum sample
Measured: 6, 12, 24, 36 months
Transferrin receptor concentration
Serum sample
Measured: 12 months of age
Transferrin saturation
serum sample
Measured: 12 months of age
Mean cell volume
Blood sample
Measured: 12 months of age
Ferritin
Serum sample
Measured: 12 months of age
Length of body
measured length at 12 mo using measuring tool for children
Measured: 12 months of age
Circumference of the head
measured at 12 mo using measuring tool for children
Measured: 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Sep 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Staffan Berglund, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442281
- Sponsor's protocol ID
- VHS
- Acronym
- VHS
- Status last verified
- May 2026
- First submitted
- 23 May 2022
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vegan Diet in Young Children - Studies of Nutritional Intake, Growth and Neurodevelopment
- ClinicalTrials.gov ID
- NCT05442281
- Acronym / sponsor ID
- VHS / VHS
- Conditions
- Vegan Diet
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 Jul 2022 (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.
Following increased knowledge about climate change and how food production affects greenhouse gas emissions, the interest in vegetarian diets is increasing. In line with this, also vegan diet is becoming more common at all ages, including in young children. But the state of knowledge regarding the effect of this diet on children during infancy and early childhood has been poorly studied and existing literature consists to a large extent of case reports.
With the main hypothesis that vegan diet from the introduction of complementary foods causes reduced bio availability of certain micronutrients important for development, the aim of this study is to examine dietary intake and development during the first years of life in a group of children eating vegan diet and compare with a reference group eating mixed diets.
In an observational study, investigators plan to include 30 children before the age of 6 months during the years 2021-2026, where the parents have decided to offer their child only vegan food. The children are studied in comparison with a reference group of 30 matched cases regarding growth, nutritional status, and dietary intake. Data collection includes monthly dietary records and blood sample analyses and growth at 6, 12 and 24 months. At the age of 3, cognitive developmental assessment (WPSSI-IV) and an DEXA examination of body composition are performed.
The study is expected to contribute to increased knowledge about the risk and benefits of vegan diets and thereby provide a better basis for future recommendations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegan diet | – | –Children fed vegan diet from 6 months of life |
| Mixed diet | – | –Children fed mixed diet from 6 months of life |
Who may qualify
- Ages
- 4 to 8 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Swedish infants mainly breastfed planned for vegan or mixed diet respectively
Key inclusion criteria (6 listed)
- Planned exclusive vegan diet or mixed diet respectively from 6 months of age until at least 2 years of life
- Exclusively (>90%) breastfed until 4 months
- Born term (GE 37+0 - 41+6)
- Single birth
- Birth weight >2500 g
Key exclusion criteria (1 listed)
- A chronic disease affecting growth or neurodevelopment
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
Concentration of Hemoglobin
Time frame: 12 months of age
Blood
Body Weight (kg)
Time frame: 12 months of age
measured weight at 12 mo using a device for measuring weight
18 secondary outcomes
Wechsler Preschool & Primary Scale of Intelligence
Time frame: 3 years of age
Fat mass index
Time frame: 3 years of age
Lean mass index
Time frame: 3 years of age
Protein intake
Time frame: at 12 months of age
Fat intake
Time frame: at 12 months of age
Carbohydrate intake
Time frame: at 12 months of age
Iron intake (mg/day)
Time frame: throughout study
B12 levels
Time frame: 6, 12, 24, 36 months
Zink level
Time frame: 6, 12, 24, 36 months
D-vitamin levels
Time frame: 6, 12, 24, 36 months
Calcium levels
Time frame: 6, 12, 24, 36 months
Homocysteine levels
Time frame: 6, 12, 24, 36 months
Transferrin receptor concentration
Time frame: 12 months of age
Transferrin saturation
Time frame: 12 months of age
Mean cell volume
Time frame: 12 months of age
Ferritin
Time frame: 12 months of age
Length of body
Time frame: 12 months of age
Circumference of the head
Time frame: 12 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Umeå University at 1 site in Sweden.
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 6 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Hemoglobin (time frame: 12 months of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.