Introduction The last national micronutrient survey of Iran showed that, in spite of a national supplementation program, the prevalence of anaemia, and zinc deficiency were 37.8% and 20% among 15-23 months old infants, respectively. Data show that more than 60% of infants do not consume supplements regular. Moreover, the current supplementation program does not provide a zinc supplement. Home fortification has been promoted as an alternative approach, where families are able to add micronutrients to home-made food for infants. The majority of efficacy trials of multiple micronutrient containing ‘Sprinkles’ powder and crushable ‘Foodlets’ tablets have been conducted in areas where maize-based complementary food is common. The potential effects of home fortification supplement in Iran are uncertain as the staple food is different (wheat and rice vs. maize in other trials) and acceptability of the Sprinkles and Foodlets is unknown. This thesis aim to assess efficacy, adherence, and acceptability of Sprinkles and Foodlets as compared with current supplement (Drops) on micronutrient status (iron, zinc, vitamin A and vitamin D) and growth in Iranian infants aged 6-18 month. Methods A total of 405 infants were recruited from Hashtgerd, 80 km west of Tehran, Iran; 43 were excluded due to not meeting the inclusion criteria. The infants were randomly assigned to receive daily supplementation of Sprinkles (n=120), Foodlets (n=121) or Drops (n=121) for four months. Sprinkles and Foodlets contain iron, zinc, vitamin A, vitamin D, folate, and multiple B vitamins similar except that levels of iron are higher in the Sprinkles group. Drops do not contain zinc, vitamin B12, or folate. The persons responsible for the laboratory test and data entry were blinded to randomization. Haemoglobin, serum ferritin, serum retinol, serum zinc, 25(OH)D concentration and anthropometric measures were assessed at baseline and four months. At each monthly phase of the follow-up, adherence to supplements and side-effects related to supplements were reported by mothers. Six focus group discussions assessed mother’s perceptions about the supplements. Within group change in means over 4 months intervention was examined by Student’s paired t-test. The within group changes in proportions were assessed using McNemar’s test. Change across the three treatment groups were compared using analysis of covariance. Ethical clearance was obtained from the ethics committee of both the University of Queensland in Australia and the Ministry of Health in Iran. Results Of the total 362 infants included in the study, 313 (86%) had complete anthropometric and haemoglobin data, and 301 infants (83%) also had both initial and final serum samples. There were no significant differences between the three groups for baseline data. Baseline data showed approximately one fourth of anaemic children had iron deficiency anaemia and 38% of infants were zinc deficient. The children had a relatively good baseline status for vitamin A, vitamin D and growth. After four months intervention mean haemoglobin increased significantly in the three groups. Serum ferritin concentration increased in the Drops group (p<0.001) and Sprinkles group (p<0.05). A significant improvement was seen in zinc status for the Sprinkles and Foodlets but not the Drops group. Mean percentage of adherence to Sprinkles, Foodlets, and Drops (total amount of supplement used divided by total amount expected to be used) was (90.4±17.25), (80.7±25.01), and (88.5±16.85) respectively. Vomiting was higher in the Foodlets compared to other groups (p<0.001). Staining of the teeth was higher in Drops than the other groups (P<0.001). Most mothers in the Sprinkles group (97.3%) preferred this supplement over current supplement whereas 87.2% of mothers in the Foodlet group preferred Foodlets over the current supplement. In the focus group discussions, mothers stated that the new supplements were more acceptable and easier to use compared to current supplement. However, they had some issues about the new supplements; for example, lack of appropriate food to add the Sprinkles or Foodlets. Conclusion The combination of multivitamins plus iron and zinc when added to wheat or rice-based complementary foods improved iron and zinc status. Combining iron and zinc in Sprinkles and Foodlets did not show negative effects on iron or zinc status. No differences were seen in efficacy of the Sprinkles and Foodlets on outcomes except a little higher improvement of iron status in Sprinkles and a slight higher weight gain of infants in the Foodlets group. According to this efficacy trial and formative study, Sprinkles had a higher acceptability in the study population and there are factors to encourage its use (easy to use, tasteless, containing all required vitamins and minerals, shape, easy to transfer, and stimulates appetite). The trial identified trade-offs in combining multiple micronutrients into a single delivery mechanism, with no benefit from addition of vitamins A and D on nutritional status in this sample of infants. We might consider different acceptability to Sprinkles in some regions by different cultural practices but in summary Sprinkles is likely to be the best option as an alternative choice to the current supplementation (Drops).

Maternal nutrition is closely linked to child health and survival. In Bangladesh there is a high prevalence of undernutrition in the form of chronic energy deficiency [CED, Body Mass Index &lt;18.5 (kg/m2)] in women and low birth weight. The aims of this thesis are to explore women’s perceptions of maternal undernutrition, to analyse the association between prenatal food supplementation and birth weight (BW), to analyse whether food- and multiple micronutrient interventions generate pro-disadvantaged equity in child survival, and to examine whether an early prenatal invitation to food supplementation and multiple micronutrient supplements (MMS) represents value for money in infant survival compared to invitation to food supplementation at usual time combined with 60 mg iron and 400 µg folic acid (standard practice). The study on women’s perceptions (n=236) was nested into the MINIMat randomized trial where women (n=4436) were allocated to early (E), or usual (U) time of invitation to prenatal food supplementation and 30 mg iron with 400 µg folic acid, or 60 mg iron with 400 µg folic acid, or MMS. Live births (n=3625) were followed-up. The analyses of equity and cost-effectiveness were based on this trial. A cohort design (n=619) was employed for the analysis of food supplements and BW. Women perceived maternal undernutrition as a serious health problem and attached very low scores to CED in pregnancy. An average of four months of prenatal food supplementation increased BW by 118 g. An early invitation to prenatal food supplementation and MMS lowered mortality in children before the age of five years and reduced social disparity in child survival chances. An increment from standard practice to E-MMS averted one extra infant death at a cost of US$797 to US$907, and saved one extra life year at a cost of US$27 to US$30. High priority should be given to the nutritional status of pregnant women in societies where undernutrition and food insecurity occurs. Prenatal food supplementation has the potential to significantly increase BW, and an early initiation of prenatal food supplementation combined with MMS was considered cost-effective in lowering infant mortality and increase social equity in child survival chances.