• S. Newton, S. Owusu-Agyei and C. Zandoh(Kintampo Health Research Centre, Ghana);

• B. Kirkwood(London School of Hygiene & Tropical Medicine)

In 1993 the WHO proposed the delivery of a post-partum dose of vitamin A (200,000IU) to mothers and three doses of 25,000IU vitamin A to young infants with each of their DPT/Polio doses. This was tested in a multi-centre trial in Ghana, India and Peru. It assessed the benefits and safety of combining maternal and low dose infant vitamin A supplementation with EPI in a placebo controlled trial. This was found to be safe but the proposed dosing regime provided only a small improvement to infant vitamin A status at 6 months of age; by 9 months when they would normally have received their first supplements the benefits from the early doses had disappeared. The WHO is currently evaluating the response in doubling the post-partum dose to 400,000IU and the child doses to 50,000IU at same EPI contacts. The trial started in September 2002 and ended in August 2004.

Objectives

1. Measure the effect of 400,000 IU of vitamin A given in two divided doses of 200,000IU to mothers and 3 doses of 50,000IU of vitamin A given to their infants concurrently with DPT/Polio immunizations, on vitamin A status at 26 weeks of age.

2. Compare the effect of such a regimen to that of the previously recommended regimen of 200,000IU of vitamin A given to mothers and 3 doses of 25,000IU of vitamin A to their infants concurrently with DPT/Polio immunizations.

3. Measure the side effects of 50,000IU of vitamin A administered with DPT/Polio immunizations.

Methods

Trained fieldworkers identify mothers soon after birth, consent is sought and they are recruited into the trial. Mother-child pairs are visited at each of the EPI visits at home at 6,10 and 14 weeks, where vitamin A doses and immunizations are administered and breast milk and blood samples collected.

Results

At 6 weeks of age (baseline) 8.2% vs 11.4% p=0.053 of the children in the intervention versus control group had low vitamin A status (MRDR ≥ 0.06) and this was 28.6% vs 25.5% p=0.33 at 9 months of age. At baseline 32.4% vs 35.3% p=0.94 of mothers had severe/moderate breast milk retinol concentrations (<20µg/dl) in the intervention vs control groups respectively; 40.1% vs 43.1% p=0.47 at 6 months and 41.8% vs 39.6% p=0.75 at 9 months in the intervention and control groups respectively. The intervention was well tolerated by infants with no serious side effects reported.

Interpretation

The trial found no evidence that the higher doses had any significant benefit over the old regime and by 9 months of age the two groups were similar in terms of their maternal breast milk retinol concentrations and their serum retinol levels.

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