Randomized comparison of efficacy, adherence, and acceptability of three multiple micronutrient supplements in Iranian infants

Kourosh Samadpour (2009). Randomized comparison of efficacy, adherence, and acceptability of three multiple micronutrient supplements in Iranian infants PhD Thesis, School of Population Health, The University of Queensland.

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Author Kourosh Samadpour
Thesis Title Randomized comparison of efficacy, adherence, and acceptability of three multiple micronutrient supplements in Iranian infants
School, Centre or Institute School of Population Health
Institution The University of Queensland
Publication date 2009-02
Thesis type PhD Thesis
Supervisor Geoffrey Marks
Mohammad Reza Hayatbakhsh
Kurt long
Total pages 134
Total black and white pages 134
Subjects 11 Medical and Health Sciences
Abstract/Summary 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).
Keyword Sprinkles, Foodlets, home fortification, multiple micronutrient supplement, infants, adherence, anaemia, zinc deficiency, infant’s growth, Iran
Additional Notes pages 53, 55, 56, 57 should be printed landscape

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Created: Sun, 28 Feb 2010, 05:53:58 EST by Dr Kourosh Samadpour on behalf of Library - Information Access Service