Pearl millet instant beverage powder enriched with baobab pulp to improve iron and anaemia status of adolescent girls in rural Ghana: a study protocol for a cluster randomised controlled trial.

Iron (Fe) deficiency anaemia is a public health concern among adolescent girls worldwide. Food-to-food fortification may be a sustainable and effective solution to Fe deficiency anaemia. However, the effect of food-to-food fortification on Fe deficiency anaemia reduction is understudied particularly in Ghana. This study seeks to investigate the efficacy of baobab pulp-fortified pearl millet beverage powder in improving the Fe and anaemia status of adolescent girls in Ghana. A three-arm cluster randomised controlled trial design, which will involve 258 anaemic adolescent girls (86/arm) selected through multi-stage cluster sampling in Kumbungu District of Ghana, will be used. Participants in arm 1 will receive 350 ml of baobab pulp-fortified pearl millet beverage, containing 13 mgFe (96 % of average RDA), 18·8 mg vitamin C (30·4 % of average RDA) and 222·1 mg citric acid, while participants in arm 2 will receive similar volume of unfortified pearl millet beverage, once a day, five times a week, for six months. Participants in arm 3 will receive the routine weekly Fe (60 mg)-folate (400 μg) supplementation for six months. Serum ferritin, C-reactive protein and haemoglobin (Hb) of participants will be assessed at baseline and end-line. The primary outcomes will be serum ferritin and Hb concentrations. Secondary outcomes will be prevalence of Fe deficiency, Fe deficiency anaemia and BMI-for-age. One-way ANOVA and paired test will be used to compare means of serum ferritin and Hb levels among and within groups, respectively. This study will provide novel concrete evidence on the efficacy of pearl millet-baobab pulp beverage powder in improving Fe and anaemia status of adolescent girls.