Dietary AssessmentNCT06094023
Dietary Intake of Folic Acid and Vitamin B12 Among Teenage Girls - Validation of Food Frequency Questionnaire
An observational study of Dietary Assessment, run by University Ghent at 1 site in Ethiopia.
Trial summary
Folate and vitamin B12 deficiencies are associated with various health issues, including anemia, cardiovascular disease, depression, and birth defects. Accurate and objective estimates of dietary intake are necessary to assess any effects of nutritional status in epidemiologic studies. Read more about this study
- Who is it for?
- Ages 13 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Assessment
- What is being tested?
- Food Frequency Questionnaire and 24 Hour food recall
- How many people
- 120 participants
- Where
- 1 siteEthiopia
- Study dates
- 6 Sep 2023to 30 Jul 2024
- How long will I take part?
- 12 Months
- 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 13 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: The study will be conducted among randomly selected teenage girls between the age of 13-19 years who resides in households at AM-HDSS. The data collection will be done at the selected teenagers' households.
Who may be able to join
- One or both of their parents signed an informed consent form and the girls agreed.
- Their parents and the girl planned to stay during the period of the study (minimum 9 months) in the kebele.
- Aged between 13 and 19 years
- Familiar with the diet and cooking practices
- Accept enumerators for home visit and data collection for one year
Who cannot join
- Teenage girls who are pregnant and/or are lactating
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site, 1 recruiting
- Recruiting
Arba Minch University
Arba Minch
Muluken Bekele Sorrie, MPH, Muluken Bekele Sorrie <MulukenBekele.Sorrie@UGent.be>
Eshetu Zerihun Tariku, MPH, Eshetu Zerihun Tariku <EshetuZerihun.Tariku@UGent.be>
About this study
Official title: Development and Validation of Food Frequency Questionnaire to Assess the Dietary Intake of Folic Acid and Vitamin B12 Among Teenage Girls in South Ethiopia.
Folate and vitamin B12 deficiencies are associated with various health issues, including anemia, cardiovascular disease, depression, and birth defects. Accurate and objective estimates of dietary intake are necessary to assess any effects of nutritional status in epidemiologic studies. This study aims to develop and validate a three-month semi-quantitative food frequency questionnaire for the assessment of dietary intake of folic acid and vitamin B12, against four*two multiple-pass 24-hr dietary recall among teenage girls in South Ethiopia
Read the detailed description
Folic acid and vitamin B12 play an interdependent role in key cellular processes, namely deoxyribonucleic acid synthesis, cell division, red blood cell formation, and nervous system myelination. Folic acid is an essential nutrient in the growth and development of the cerebral cortex. It promotes the thickness of the cerebral cortex; which is directly proportional to the intelligence quotient, the neurocognitive and psychological development of the child. Both folate and vitamin B12 participate in the conversion of homocysteine to methionine, such that a deficiency in either vitamin will result in elevated serum concentrations of homocysteine where high levels of serum homocysteine are associated with an increased risk for depression. Deficiencies in folate and vitamin B12 have been shown to delay growth spurt and pubertal growth during adolescence. Some studies also showed that there is an association between overweight and obesity with lower serum vitamin B12 and folate levels.
In research, there are several challenges in the accurate assessment of diet and nutrition. In the Ethiopian context, there is no tool that specifically assesses dietary intake of folic acid and vitamin B12 in adolescents. In this project, reliable dietary assessment tools for assessing dietary intake of folic acid and vitamin B12 will be developed and validated for future use as an unbiased reference measure. The dietary validation study will start by conducting a food frequency questionnaire (FFQ). The FFQ will consider the recall time frame of the previous three months assuming that the consumption patterns for folate and vitamin B12-rich foods of participants over a three-month period can be considered as their usual food intake. The FFQ will be administered to the selected study participants four times: at the beginning of the validation study, after 3 and 6 months, and at 9 months (the end of the study). The same participants will be also asked to complete two 24-hour food recalls every three months in a nine-month period. The first 24-hour recall questionnaires will be collected at least one week after the first FFQ, and one within the 3-month period considering one weekday and one weekend day. A total of eight 24-hour food recalls and four FFQs will be collected.
Study objective
The objective of this sub study is to develop and validate a FFQ that can be used to assess the dietary intake of folic acid and vitamin B12 among teenage girls who reside in rural communities of Arba Minch Health and Demographic Surveillance Sites (AM-HDSS), South Ethiopia.
- Conditions
- Dietary Assessment
- Being tested
- Food Frequency Questionnaire, 24 Hour food recall
- Keywords
- Dietary assessment, Food Frequency Questionnaire, Multi-pass 24 hour food recall, Semi-quantitative, Vitamin B12, Folic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Frequency QuestionnaireOther
Food frequency questionnaires (FFQs) are a common method for measuring dietary intake in large epidemiological studies, in particular in low literacy settings were diaries and food history would not be viable.
24 Hour food recallOther
Standardized and validated approach of collecting all foods, beverages, and supplements consumed during the past 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Teenage girls between 13 and 19 years living in the Arba Minch Demographic and Surveillance site. | Participants in this study should be acquainted with cooking practices to be able to cite all the ingredients that are used in the preparation of the dishes/ meals Receives: Other: Food Frequency Questionnaire; Other: 24 Hour food recall |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Mean/Median proportion of folic acid intake assessed by the 24 hour recalls
Mean/Median proportion of folic acid intake from (Cereal and cereal products, Tubers \& Roots, Legumes \& Legume products, Vegetables, Fruit \& Berries, Meat \& Poultry, Fish, Dairy products, Egg, Sugars, Oil, Fat, Oil seeds \& nuts, Herbs \& spices , soft drinks and beverages) assessed by 24 hour recalls The recommended intake for folic acid for teenage girls aged between 13 and 19 years is set at 400 micrograms/day
Measured: 12 month
2. Mean/median proportion of folic acid intake assessed by the food frequency questionnaire
Mean/Median proportion of folic acid intake from (Cereal and cereal products, Tubers \& Roots, Legumes \& Legume products, Vegetables, Fruit \& Berries, Meat \& Poultry, Fish, Dairy products, Egg, Sugars, Oil, Fat, Oil seeds \& nuts, Herbs \& spices , soft drinks and beverages) assessed by food frequency questionnaire.
The recommended intake for folic acid for teenage girls aged between 13 and 19 years is set at 400 micrograms/day
Measured: 12 month
3. Mean/median proportion of vitamin B12 intake assessed by the 24 hour recalls
Mean/Median proportion of vitamin B12 intake from (Meat \& Poultry, Fish, Dairy products, Egg, soft drinks and beverages) assessed by 24 hour recalls
The recommended intake for vitamin B12 for teenage girls aged between 13 and 19 years is set at 2.4 micrograms/day
Measured: 12 month
4. Mean/median proportion of vitamin B12 intake assessed by the food frequency questionnaire
Mean/Median proportion of vitamin B12 intake from (Meat \& Poultry, Fish, Dairy products, Egg, soft drinks and beverages) assessed by food frequency questionnaire
The recommended intake for vitamin B12 for teenage girls aged between 13 and 19 years is set at 2.4 micrograms/day
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start6 Sep 2023
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dietary AssessmentStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Arba Minch University, Institut de Recherche en Sciences de la Sante, Burkina Faso, Addis Ababa University
- Responsible party
- Sponsor
- Investigators
- Stefaan De Henauw, MD. PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094023
- Sponsor's protocol ID
- ONZ-2023-0137-A
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Institute of Medicine (US) Standing Committee on the Scientific Evaluation of Dietary Reference Intakes and its Panel on Folate, Other B Vitamins, and Choline. Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Washington (DC): National Academies Press (US); 1998. Available from http://www.ncbi.nlm.nih.gov/books/NBK114310/
PubMed 23193625Beydoun MA, Shroff MR, Beydoun HA, Zonderman AB. Serum folate, vitamin B-12, and homocysteine and their association with depressive symptoms among U.S. adults. Psychosom Med. 2010 Nov;72(9):862-73. doi: 10.1097/PSY.0b013e3181f61863. Epub 2010 Sep 14.
PubMed 20841559
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Food Frequency Questionnaire to Assess the Dietary Intake of Folic Acid and Vitamin B12 Among Teenage Girls in South Ethiopia.
- ClinicalTrials.gov ID
- NCT06094023
- Acronym / sponsor ID
- ONZ-2023-0137-A
- Conditions
- Dietary Assessment
- Keywords
- Dietary assessment, Food Frequency Questionnaire, Multi-pass 24 hour food recall, Semi-quantitative, Vitamin B12, Folic acid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Arba Minch University, Institut de Recherche en Sciences de la Sante, Burkina Faso, Addis Ababa University
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 23 Oct 2023 (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.
Folate and vitamin B12 deficiencies are associated with various health issues, including anemia, cardiovascular disease, depression, and birth defects. Accurate and objective estimates of dietary intake are necessary to assess any effects of nutritional status in epidemiologic studies. This study aims to develop and validate a three-month semi-quantitative food frequency questionnaire for the assessment of dietary intake of folic acid and vitamin B12, against four*two multiple-pass 24-hr dietary recall among teenage girls in South Ethiopia
Detailed description
Folic acid and vitamin B12 play an interdependent role in key cellular processes, namely deoxyribonucleic acid synthesis, cell division, red blood cell formation, and nervous system myelination. Folic acid is an essential nutrient in the growth and development of the cerebral cortex. It promotes the thickness of the cerebral cortex; which is directly proportional to the intelligence quotient, the neurocognitive and psychological development of the child. Both folate and vitamin B12 participate in the conversion of homocysteine to methionine, such that a deficiency in either vitamin will result in elevated serum concentrations of homocysteine where high levels of serum homocysteine are associated with an increased risk for depression. Deficiencies in folate and vitamin B12 have been shown to delay growth spurt and pubertal growth during adolescence. Some studies also showed that there is an association between overweight and obesity with lower serum vitamin B12 and folate levels.
In research, there are several challenges in the accurate assessment of diet and nutrition. In the Ethiopian context, there is no tool that specifically assesses dietary intake of folic acid and vitamin B12 in adolescents. In this project, reliable dietary assessment tools for assessing dietary intake of folic acid and vitamin B12 will be developed and validated for future use as an unbiased reference measure. The dietary validation study will start by conducting a food frequency questionnaire (FFQ). The FFQ will consider the recall time frame of the previous three months assuming that the consumption patterns for folate and vitamin B12-rich foods of participants over a three-month period can be considered as their usual food intake. The FFQ will be administered to the selected study participants four times: at the beginning of the validation study, after 3 and 6 months, and at 9 months (the end of the study). The same participants will be also asked to complete two 24-hour food recalls every three months in a nine-month period. The first 24-hour recall questionnaires will be collected at least one week after the first FFQ, and one within the 3-month period considering one weekday and one weekend day. A total of eight 24-hour food recalls and four FFQs will be collected.
Study objective
The objective of this sub study is to develop and validate a FFQ that can be used to assess the dietary intake of folic acid and vitamin B12 among teenage girls who reside in rural communities of Arba Minch Health and Demographic Surveillance Sites (AM-HDSS), South Ethiopia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teenage girls between 13 and 19 years living in the Arba Minch Demographic and Surveillance site. | – | Other: Food Frequency Questionnaire, Other: 24 Hour food recallParticipants in this study should be acquainted with cooking practices to be able to cite all the ingredients that are used in the preparation of the dishes/ meals |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study will be conducted among randomly selected teenage girls between the age of 13-19 years who resides in households at AM-HDSS. The data collection will be done at the selected teenagers' households.
Key inclusion criteria (5 listed)
- One or both of their parents signed an informed consent form and the girls agreed.
- Their parents and the girl planned to stay during the period of the study (minimum 9 months) in the kebele.
- Aged between 13 and 19 years
- Familiar with the diet and cooking practices
- Accept enumerators for home visit and data collection for one year
Key exclusion criteria (1 listed)
- Teenage girls who are pregnant and/or are lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food Frequency QuestionnaireFood frequency questionnaires (FFQs) are a common method for measuring dietary intake in large epidemiological studies, in particular in low literacy settings were diaries and food history would not be viable. | Other | Teenage girls between 13 and 19 years living in the Arba Minch Demographic and Surveillance site. |
| 24 Hour food recallStandardized and validated approach of collecting all foods, beverages, and supplements consumed during the past 24 hours. | Other | Teenage girls between 13 and 19 years living in the Arba Minch Demographic and Surveillance site. |
Primary outcome
1. Mean/Median proportion of folic acid intake assessed by the 24 hour recalls
Time frame: 12 month
Mean/Median proportion of folic acid intake from (Cereal and cereal products, Tubers \& Roots, Legumes \& Legume products, Vegetables, Fruit \& Berries, Meat \& Poultry, Fish, Dairy products, Egg, Sugars, Oil, Fat, Oil seeds \& nuts, Herbs \& spices , soft drinks and beverages) assessed by 24 hour recalls The recommended intake for folic acid for teenage girls aged between 13 and 19 years is set at 400 micrograms/day
2. Mean/median proportion of folic acid intake assessed by the food frequency questionnaire
Time frame: 12 month
Mean/Median proportion of folic acid intake from (Cereal and cereal products, Tubers \& Roots, Legumes \& Legume products, Vegetables, Fruit \& Berries, Meat \& Poultry, Fish, Dairy products, Egg, Sugars, Oil, Fat, Oil seeds \& nuts, Herbs \& spices , soft drinks and beverages) assessed by food frequency questionnaire. The recommended intake for folic acid for teenage girls aged between 13 and 19 years is set at 400 micrograms/day
3. Mean/median proportion of vitamin B12 intake assessed by the 24 hour recalls
Time frame: 12 month
Mean/Median proportion of vitamin B12 intake from (Meat \& Poultry, Fish, Dairy products, Egg, soft drinks and beverages) assessed by 24 hour recalls The recommended intake for vitamin B12 for teenage girls aged between 13 and 19 years is set at 2.4 micrograms/day
4. Mean/median proportion of vitamin B12 intake assessed by the food frequency questionnaire
Time frame: 12 month
Mean/Median proportion of vitamin B12 intake from (Meat \& Poultry, Fish, Dairy products, Egg, soft drinks and beverages) assessed by food frequency questionnaire The recommended intake for vitamin B12 for teenage girls aged between 13 and 19 years is set at 2.4 micrograms/day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 23193625Institute of Medicine (US) Standing Committee on the Scientific Evaluation of Dietary Reference Intakes and its Panel on Folate, Other B Vitamins, and Choline. Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Washington (DC): National Academies Press (US); 1998. Available from http://www.ncbi.nlm.nih.gov/books/NBK114310/
- Background: PubMed 20841559Beydoun MA, Shroff MR, Beydoun HA, Zonderman AB. Serum folate, vitamin B-12, and homocysteine and their association with depressive symptoms among U.S. adults. Psychosom Med. 2010 Nov;72(9):862-73. doi: 10.1097/PSY.0b013e3181f61863. Epub 2010 Sep 14.
- 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.
Stefaan De Henauw, MD. PhD principal investigator
University Ghent
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 Dietary Assessment, run by University Ghent at 1 site in Ethiopia.
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 5 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. 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 Ethiopia. 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 Souheila Abbeddou, MSc. PhD (+32467630892, Souheila.Abbeddou@UGent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Mean/Median proportion of folic acid intake assessed by the 24 hour recalls (time frame: 12 month). The study lists 4 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 NCT06094023, which also lists 2 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 23 Oct 2023.