Puzzling result?

New Delhi, April 18: Vitamin A, long touted as a method to reduce child mortality, has no effect on deaths among children in India, the world’s largest trial has shown.

Four years after the Vitamin A study was completed on a million children from across some 8,000 towns in Uttar Pradesh, its results remain unpublished in any medical journal.

But sections of India’s medical community are using it to fortify their argument that the health ministry has been spending scarce resources on a nationwide Vitamin A supplementation that may not be delivering its promised benefits.

The health ministry provides Vitamin A annually to about 55 million children between the ages of nine months and five years at community health centres. The programme was motivated by earlier studies indicating that Vitamin A reduces mortality in this age group by 20 to 30 per cent, mainly by strengthening immunity against infections.

But the study by doctors at the King George Medical College, Lucknow, from 1999 to 2004 revealed no significant difference in the death rates between children who received Vitamin A and those who did not.

Critics argue that unless the results are published in a peer-reviewed journal, they are unlikely to be taken into account in changing policy on Vitamin A.

“Was a trial done on a million Indian children for its results to remain unused for so long?” asked H.P.S. Sachdev, a paediatrician at the Sitaram Bhartiya Institute of Science and Research, New Delhi, and former president of the Indian Academy of Paediatrics.

“If the study was intended to feed policy, its findings should have been published or the results communicated to the government,” Sachdev said.

Doctors involved in the study admit they are puzzled by its findings.

“We didn’t observe an effect on mortality,” said Shally Awasthi, a paediatrician at the King George Medical College, who was the study’s principal investigator.

“I don’t know how to account for our data,” said Richard Peto, professor of medical epidemiology at the University of Oxford and a study collaborator. “We don’t understand why we didn’t see an effect on the mortality,” Peto said.

Both Peto and Awasthi said the findings had been presented at a conference in Istanbul, Turkey, last year. “The findings are in the public domain. We’re trying to publish this in a journal,” Awasthi said.

The study compared death rates over five years among nearly a million children, half given Vitamin A supplementation and the other half not given the vitamin. The death rate was 24.9 per 1,000 in the Vitamin A group, and 26 per 1,000 in the other group.

But officials involved in Vitamin A supplementation programmes argue that there is still evidence of mortality reduction from previous studies in India and elsewhere.

“We would not advise a change in policy,” said Luc Laviolette, regional director of the Micronutrient Initiative, a non-government organisation that supports Vitamin A delivery in several states.

“Policy decisions should be based on evidence, and collectively a number of studies suggest that Vitamin A reduces mortality by about 23 per cent and the mortality reduction is highest in South Asia,” he said.

But critics argue that in ignoring the Uttar Pradesh study, policy-makers are merely turning a blind eye to unfavourable results.

“The issue of Vitamin A has commercial undertones,” said Umesh Kapil, professor of public health nutrition at the All India Institute of Medical Sciences, New Delhi.

“If you take this large study into account, the mortality reduction figure drops and India needs to do a fresh cost-benefit analysis on whether Vitamin A should be given nationwide,” Kapil said. “Maybe it should be administered selectively in pockets where there is a need.”