Ten2Twenty-Ghana: A Randomized Controlled Trial on the Efficacy of Multiple-Micronutrient Fortified Biscuits on the Micronutrient Status of Adolescent Girls.

Adolescent girls are an important target group for micronutrient interventions particularly in Sub-Saharan Africa where adolescent pregnancy and micronutrient deficiencies are common. When consumed in sufficient amounts and at levels appropriate for the population, fortified foods may be a useful strategy for this group, but little is known about their effectiveness and timing (with regard to menarche), particularly in resource-poor environments. We evaluated the effect of consuming multiple-micronutrient fortified biscuits (MMB), sold in the Ghanaian market, 5 days/week for 26 weeks compared to unfortified biscuits (UB) on the micronutrient status of female adolescents. We also explored to what extent the intervention effect varied before or after menarche. Ten2Twenty-Ghana was a 26-week double-blind, randomized-controlled trial among adolescent girls aged 10-17 years ( n =621) in the Mion District, Ghana. Biomarkers of micronutrient status included concentrations of haemoglobin, plasma ferritin (PF), soluble transferrin receptor concentration (TfR) and retinol-binding protein (RBP), including body-iron stores. Intention-to-treat analysis was supplemented by protocol-specific analysis. We found no effect of the intervention on PF, TfR and RBP. MMB consumption did not affect anaemia and micronutrient deficiencies at the population level. MMB consumption increased the prevalence of vitamin A deficiency by 6.2% (95% CI 0.7%, 11.6%) among pre-menarche girls when adjusted for baseline micronutrient status, age, and height-for-age z-score, but it decreased the prevalence of deficient/low vitamin A status by -9.6% (95% CI -18.9%, -0.3%) among post-menarche girls. Consuming MMB available in the market did not increase iron status in our study, but it reduced the prevalence of deficient/low vitamin A status in post-menarcheal girls.