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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


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06094023
Study type Observational [Patient Registry]
Source University Ghent
Contact Souheila Abbeddou, MSc. PhD
Phone +32467630892
Email Souheila.Abbeddou@UGent.be
Status Recruiting
Phase
Start date September 6, 2023
Completion date July 30, 2024

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