Dietary Intake of Folic Acid and Vitamin B12 Among Teenage Girls - Validation of Food Frequency Questionnaire

Dietary Assessment Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094023
• Other study ID #: ONZ-2023-0137-A
• Status: Recruiting
• Start date: September 6, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: October 2023
• Source: University Ghent
• Contact: Souheila Abbeddou, MSc. PhD
• Phone: +32467630892
• Email: Souheila.Abbeddou[@]UGent.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 19 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Teenage girls who are pregnant and/or are lactating

Related Conditions & MeSH terms

• Dietary Assessment

Intervention

Other:
• Food Frequency Questionnaire
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 recall
Standardized and validated approach of collecting all foods, beverages, and supplements consumed during the past 24 hours.

Locations

Country	Name	City	State
Ethiopia	Arba Minch University	Arba Minch

Sponsors (4)

Lead Sponsor	Collaborator
University Ghent	Addis Ababa University, Arba Minch University, Institut de Recherche en Sciences de la Sante, Burkina Faso

Country where clinical trial is conducted

Ethiopia, 

References & Publications (2)

Beydoun 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. — View Citation

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 month
Primary	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	12 month
Primary	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	12 month
Primary	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	12 month