To measure the impact of supplementation with zinc alone and a combination of zinc and vitamin A on:
* the outcome of acute diarrhoea, particularly the risk of persistence.
* moderately malnourished children of 6-23 months of age.
The study will assess whether daily supplementation with zinc alone or zinc combined with vitamin A substantially reduces the severity and duration of acute diarrhoea and the nutritional insult of, particularly prolonged, diarrhoeal illness. If so, it is desirable and feasible to implement this reasonable intervention in national programmes, an intervention which will be particularly relevant to the 20% of children who experience recurrent diarrhoea and impaired physical growth.
Demonstrating the postulated benefits of micronutrient supplementation has other important programmatic implications, for example in influencing which foods should be promoted during nutritional counselling, the choice of diets to be offered in supplementation schemes and strategies for micronutrient food fortification, e.g. of domestic salt, wheat flour and animal milk.
The efficacy of micronutrient supplementation will be assessed in a two-centre placebo-controlled community-based trial where project staff will administer a single large dose of vitamin A upon enrolment and zinc 5 days per week until 12 weeks following recovery.
The study will enrol a total of 1,600 children who will be followed up twice weekly to measure the impact on:
* enrolment diarrhoeal episode (duration of diarrhoea, number of diarrhoeal stools during the episode, proportion of episodes that become persistent, and change in weight during the episode)
* subsequent diarrhoeal morbidity over 12 weeks (incidence of acute diarrhoea and persistent diarrhoea, and daily diarrhoea prevalence)
* growth over 12 weeks after recovery (change in weight and length/height and risk of developing severe malnutrition)
Furthermore, the effect of zinc supplementation on serum and hair zinc levels and on the severity of the enrolment episode will be measured after a programmatically relevant delivery approach, namely administration of zinc by mothers.
Comparison of baseline features including hair- and serum-zinc levels will be made to confirm comparability across intervention groups. Outcome measures will be compared across the intervention groups initially on an "intent-to-treat-basis". Further analyses using generalised linear models will be performed to adjust for any imbalance at baseline and to take into account intervention compliance.
Funding SchemeCSC - Cost-sharing contracts
110029 New Delhi