Effectiveness of Fortification With Folic Acid and Vitamin B12 Among Teenage Girls
- Conditions
- Anemia, MegaloblasticFolate DeficiencyVitamin B 12 DeficiencyCognitive DevelopmentDepressive Symptoms
- Interventions
- Other: Unfortified cereal flourDietary Supplement: Folic acid and vitamin B12 fortified flour
- Registration Number
- NCT06100146
- Lead Sponsor
- University Ghent
- Brief Summary
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. A deficiency of either vitamin will predispose teenagers to many diseases, which persist across their lifespan. Fortification of food with micronutrients has been promoted to reduce micronutrient deficiencies. A large segment of vulnerable populations in low- and middle-income countries (LMICs) resides in rural settings and has limited access to large-scale commercialized fortified foods. In such operational constraints, the use of locally (small-scale) fortified cereals could be an alternative intervention. The study aims to evaluate the effectiveness of small scale folic acid and vitamin B12 fortified cereals in improving folate and vitamin B12 status, growth velocity, puberty status, anaemia, cognitive development and mental health among teenage girls, in rural rift valley of Ethiopia.
- Detailed Description
Folic acid (FA) 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. Teenagers are the future mothers. Hence their health and nutritional status have long term consequences on future pregnancies and birth outcomes. Neural Tube Defects (NTDs) are a group of fatal or severely disabling birth defects known to be mainly a consequence of severe folate deficiency in early pregnancy. The policy of advising women to take iron \& FA (IFA) supplements during pregnancy has not been successful in preventing NTDs because of the low adherence to antenatal care services including IFA, the large proportion of unplanned pregnancies, the timing at which IFA supplementation starts, and the logistical limitation that makes the access to IFA limited. The evidence is strong on the importance of food fortification in the promotion of maternal and child health mainly through reducing micronutrient deficiencies. A large segment of vulnerable populations in developing countries resides in rural settings and has limited access to fortified foods in the market. In such operational constraints, using locally fortified cereals could be an alternative intervention. However, there is a paucity of evidence regarding effectiveness of small-scale cereal-based fortification; in Ethiopia, the evidence is inexistent. Moreover, teenage girls are an under-studied group and do not constitute a target population from different nutritional intervention programs.
The overall objective of this study is to evaluate the effectiveness of small-scale folic acid and vitamin B12-fortified cereals in improving folate and vitamin B12 status, growth velocity, puberty status, anaemia, cognitive development and mental health among rural teenage girls (13-19 years of age).
This study will be conducted in Arba Minch Health and Demographic Surveillance Sites (AM-HDSS), Southern Ethiopia from October 2023 to April 2024. Effectiveness of intake of folic acid and vitamin B12 fortified meals will be evaluated in a randomized, double-blind controlled trial among 474 teenage girls between 13 and 19 years of age who are residing in and attending one of the schools at AM-HDSS.
Data on the following variables, except for demographic characteristics of teenage girls and their respective parents and/or household heads will be collected at the start and end point of the 6 months intervention. Data collection will be carried out at schools and at respective girls' home.
* Demographic characteristics of the teenage girls, morbidity status, helminthic infections, dietary intake, anthropometry, puberty status, presence of depressive symptoms, biochemical samples and cognitive development will be assessed in teenage girls directly at schools.
* Socio-demographic characteristics of the parents or the head of the household if different from parents, family wealth status, food security, health care services and environmental characteristics will be collected in recruited teenage girls' households within the one week following the enrolment and at the end of the intervention.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 474
Teenage girls between 13 and 19 years of age who live in households at Arba Minch Health and Demographic Surveillance Sites (AM-HDSS) are eligible to participate in the study if:
- One or both of their parents signed an informed consent form and the girl's agreement.
- Their parents and the girl planned to stay in the study area during the period of the study (minimum 6 months) in the kebele.
- Both parents and girls accept the intervention packages including blood draws and home visits.
- Chronically ill girls diagnosed with diabetes and asthma;
- Severely undernourished girls (defined as body mass index z score < -3 standard deviations of the median World Health Organization reference population);
- Severely anaemic girls (Hb concentration <80g/L);
- Teenage girls who are pregnant, lactating or taking IFA/B12 supplements;
- Diagnosed hemoglobinopathy (sickle cell or thalassemia);
- Diagnosed liver diseases like acute hepatitis, cirrhosis, hepatocellular carcinoma, and metastatic liver disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Unfortified cereal flour Teenage girls randomly assigned to the control group will receive a standard bag of unfortified cereal flours every week for six months. folic acid & vit B12 fortified flour Folic acid and vitamin B12 fortified flour Teenage girls randomly assigned to the control group will receive a standard bag of cereal flours fortified with folic acid and Vit B12 every week for six months.
- Primary Outcome Measures
Name Time Method Serum vitamin B12 concentrations Assessed at 6 months Serum vitamin B12 level (pmol/L)
General cognitive ability Assessed at 6 months Raven Progressive Matrices (RPM) tests, a measure of nonverbal intelligence.
Depression Assessed at 6 months Depressive symptoms will be assessed by Patient Health Questionnaire (PHQ) 9 modified for adolescents (PHQ-9A), a self-report instrument comprised of 9-items. Items are rated on a four-point ordinal scale.
Fat-free mass Assessed at 6 months An index of adiposity will be measured to evaluate girls' body composition, in %
Erythrocyte (RBC) folic acid concentrations Assessed at 6 months RBC folate level ng/ml (nmol/l)
Working memory Assessed at 6 months Digit Span (Forward, Backward, and Sequencing) is a standardized test that assesses the working memory of participants.
Serum folic acid concentrations Assessed at 6 months Serum folate levels ng/ml (nmol/l)
Fat mass Assessed at 6 months An index of adiposity will be measured to evaluate girls' body composition, in kg
- Secondary Outcome Measures
Name Time Method Weight Assessed at 3 and 6 months Participant weight (kg)
RBC structure (megaloblastic anaemia) Assessed at 6 months Mean Corpuscular Volume (MCV) in femtoliters/fl
Plasma homocysteine concentrations Assessed at 6 months Plasma homocysteine level (µmol/L)
Adherence to the intervention/fortification Assessed weekly for the whole period of intervention (until 6 months) adherence to the flour consumption will be assessed through home to home visit in a weekly basis.
Haemoglobin concentration Assessed at 6 months Haemoglobin concentration (g/dl)
Prevalence of soil-transmitted helminths Assessed at 6 months The presence of worm parasites and egg density in the stools. Three common parasites and their eggs will be investigated, i.e. Ascaris lumbricoides (round worm), Trichuris trichiura (whipworm) and Ancyclostoma duodenale or Necater americanus (hookworms)
Height Assessed at 6 months Participant height (cm)
Puberty status Assessed at 6 months of fortification The pubertal status will be assessed by Pubertal Development Scale which has a 4-point scale ranging from 1 (has not begun) to 4 (development completed). Girls will report on their body hair development, growth spurt, skin changes, breast development and the occurrence of menarche (1=no and 4=yes).
Prevalence of Schistosome infection Assessed at 6 months The prevalence of Schistosoma mansoni infection
Trial Locations
- Locations (2)
Arba Minch Health and Demographic Surveillance System sites
🇪🇹Arba Minch, Ethiopia
Arba Minch University
🇪🇹Arba Minch, Ethiopia