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

NCT06094023 | Unknown

• 1 other identifier: ONZ-2023-0137-A
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dietary Assessment

Keywords

Dietary assessment; Food Frequency Questionnaire; Multi-pass 24 hour food recall; Semi-quantitative; Vitamin B12; Folic acid

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

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

Other: Food Frequency Questionnaire; Other: 24 Hour food recall

Interventions

Food Frequency Questionnaire OTHER

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.

Teenage girls between 13 and 19 years living in the Arba Minch Demographic and Surveillance site.

24 Hour food recall OTHER

Standardized and validated approach of collecting all foods, beverages, and supplements consumed during the past 24 hours.

Teenage girls between 13 and 19 years living in the Arba Minch Demographic and Surveillance site.

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Teenage girls who are pregnant and/or are lactating

Sponsors & Collaborators

• University Ghent: lead
• Arba Minch University: collaborator
• Institut de Recherche en Sciences de la Sante, Burkina Faso: collaborator
• Addis Ababa University: collaborator

Study Sites (1)

Arba Minch University

Arba Minch, Ethiopia

RECRUITING

Related Publications (2)

• 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/

  PMID: 23193625 BACKGROUND

• 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.

  PMID: 20841559 BACKGROUND

Study Officials

• Stefaan De Henauw, MD. PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Souheila Abbeddou, MSc. PhD

CONTACT

+32467630892; Souheila.Abbeddou@UGent.be

Muluken Bekele Sorrie, MPH

CONTACT

+251920256806; mulukenbekele.sorrie@ugent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 23, 2023
• Study Start: September 6, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)