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The Prevention Of Vitamin A Deficiency In Young Infants By Supplementation Alongside Routine Vaccinations Delivered Through The Expanded Programme On Immunisation: A Randomised Controlled Trial

Investigator(s):

Kahigwa E, Schellenberg D, Ross DA, Mshinda H. Bunini W,  Mukasa O, Masanja H,   Aponte J, Urassa H, Armstrong Schellenberg J.

Institution(s):

Ifakara Health Research and Development Centre, Saint Francis Designated District Hospital, Hospital Clinic Barcelona, London School of Hygiene and Tropical Medicine

Summary:

Vitamin A Deficiency (VAD) is a common problem worldwide and a problem of public health significance in Tanzania. VAD has been associated with a substantial increase in mortality in 6 –11 month old infants and supplementation with vitamin A in children above 6 months has been shown to reduce morbidity and mortality. Given the high prevalence of VAD at 6 months of age, and the high mortality before this age, there is a need to investigate the safety and efficacy of supplementation before this age.

  The primary objectives of the trial are to:

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

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

3.        Measure the short-term side effects of each of the two doses of 200,000 IU given to mothers, and of the 50,000 IU of vitamin A administered with each of the three DPT/Polio immunisations.

It is a randomised, double blind, controlled trial in 770 infants recruited within a few days of birth and followed up to 9 months of age. Children and their mothers are randomised to one of two groups. Mothers in the first group receive 200,000IU vitamin A shortly after delivery, when bringing their child for BCG vaccination, and their children receive 25,000IU vitamin A at the time of DTP doses 1,2, and 3. Mothers in the second group  receive 200,000IU vitamin A at the time of BCG vaccination of the child and a further 200,000IU at the time of the child’s first DTP vaccination. In addition, the child receives 50,000IU vitamin A at the time of doses 1, 2 and 3 of DTP.

Safety is assessed by active follow-up of mothers and children for 48hr after each dose and through passive clinical surveillance at St.Francis hospital. The primary outcomes of the trial will be the prevalence of VAD and of severe VAD in the infant at six months of age, and the incidence of adverse effects in particular bulging fontanelle, temperature >37.5^oC, vomiting, diarrhoea and inability to suck/feed in the infant during the two days after each dose of vitamin A.

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