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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
474
Standard bags of fortified cereal-based flours will be prepared at local mills from the common staple cereal food in the area. The dose of vitamins will be added to the flour of the intervention group and mixed with batch mixing technique. The concentration of folic acid and vitamin B12 per 1kg of flour will be 2mg and 0.02mg, respectively. Participants will be supplied with 6 kg bags of flour, which will be enough for 30 days, and 1.5kg bags of flour will be delivered to their home on a weekly basis and lasting for 6 months. Instructions on the preparation of meals and frequency of intake with a weekly compliance sheet will be provided for monitoring the intervention.
Standard bags of unfortified cereal-based flours will be prepared at local mills from the common staple cereal food in the area. Participants will be supplied with 6 kg bags of flour, which will be enough for 30 days, and 1.5kg bags of flour will be delivered to their home on a weekly basis and lasting for 6 months. Instructions on the preparation of meals and frequency of intake with a weekly compliance sheet will be provided for monitoring the intervention.
Arba Minch Health and Demographic Surveillance System sites
Arba Minch, Ethiopia
RECRUITINGArba Minch University
Arba Minch, Ethiopia
NOT_YET_RECRUITINGSerum folic acid concentrations
Serum folate levels ng/ml (nmol/l)
Time frame: Assessed at 6 months
Erythrocyte (RBC) folic acid concentrations
RBC folate level ng/ml (nmol/l)
Time frame: Assessed at 6 months
General cognitive ability
Raven Progressive Matrices (RPM) tests, a measure of nonverbal intelligence.
Time frame: Assessed at 6 months
Working memory
Digit Span (Forward, Backward, and Sequencing) is a standardized test that assesses the working memory of participants.
Time frame: Assessed at 6 months
Depression
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.
Time frame: Assessed at 6 months
Serum vitamin B12 concentrations
Serum vitamin B12 level (pmol/L)
Time frame: Assessed at 6 months
Fat-free mass
An index of adiposity will be measured to evaluate girls' body composition, in %
Time frame: Assessed at 6 months
Fat mass
An index of adiposity will be measured to evaluate girls' body composition, in kg
Time frame: Assessed at 6 months
RBC structure (megaloblastic anaemia)
Mean Corpuscular Volume (MCV) in femtoliters/fl
Time frame: Assessed at 6 months
Plasma homocysteine concentrations
Plasma homocysteine level (µmol/L)
Time frame: Assessed at 6 months
Weight
Participant weight (kg)
Time frame: Assessed at 3 and 6 months
Adherence to the intervention/fortification
adherence to the flour consumption will be assessed through home to home visit in a weekly basis.
Time frame: Assessed weekly for the whole period of intervention (until 6 months)
Haemoglobin concentration
Haemoglobin concentration (g/dl)
Time frame: Assessed at 6 months
Height
Participant height (cm)
Time frame: Assessed at 6 months
Puberty status
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).
Time frame: Assessed at 6 months of fortification
Prevalence of soil-transmitted helminths
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)
Time frame: Assessed at 6 months
Prevalence of Schistosome infection
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The prevalence of Schistosoma mansoni infection
Time frame: Assessed at 6 months