Impact of supplementing newborn infants with vitamin A on early infant mortality: community based randomised trial in southern IndiaBMJ 2003; 327 doi: https://doi.org/10.1136/bmj.327.7409.254 (Published 31 July 2003) Cite this as: BMJ 2003;327:254
- Lakshmi Rahmathullah, director1,
- James M Tielsch, professor ()2,
- R D Thulasiraj, executive director3,
- Joanne Katz, professor2,
- Christian Coles, assistant research professor2,
- Sheela Devi, research coordinator3,
- Rajeesh John, biostatistician3,
- Karthik Prakash, biostatistician3,
- A V Sadanand, faculty3,
- N Edwin, professor4,
- C Kamaraj, professor4
- 1Aravind Centre for Women, Children and Community Health, Madurai, Tamil Nadu, India
- 2Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD 21205-2103, USA
- 3Lions-Aravind Institute for Community Ophthalmology, Madurai, Tamil Nadu, India
- 4Department of Pediatrics, Madurai Medical College, Madurai, Tamil Nadu, India
- Correspondence to: J M Tielsch
- Accepted 16 April 2003
Objective To assess the impact of supplementing newborn infants with vitamin A on mortality at age 6 months.
Design Community based, randomised, double blind, placebo controlled trial.
Setting Two rural districts of Tamil Nadu, southern India.
Participants 11 619 newborn infants allocated 24 000 IU oral vitamin A or placebo on days 1 and 2 after delivery.
Main outcome measure Primary outcome measure was mortality at age 6 months.
Results Infants in the vitamin A group had a 22% reduction in total mortality (95%confidence interval 4% to 37%) compared with those in the placebo group. Vitamin A had an impact on mortality between two weeks and three months after treatment, with no additional impact after three months.
Conclusion Supplementing newborn infants with vitamin A can significantly reduce early infant mortality.
Contributors LR, JT, RDT, and JK helped design the study. LR, JT, RDT, CC, SD, and AVS supervised the conduct of the study, JT, RDT, JK, RJ, and KP were involved in the analysis and interpretation of the data. LR, CC, NE, and CK were involved in the interpretation of the data. JK and KP designed the data management system. NE and CK reviewed the verbal autopsies and determined the cause of death for the study. All authors contributed to writing or editing the manuscript, or both. JT will act as guarantor for the paper.
Funding This study received support from Cooperative Agreement No HRN-A-00-97-00015-00 between the Center for Human Nutrition (Bloomberg School of Public Health, Johns Hopkins University) and the Office of Health and Nutrition (US Agency for International Development, Washington DC), the Bill and Melinda Gates Foundation (Seattle, Washington), and Task Force Sight and Life (Basel, Switzerland). These financial supporters had no role in the design, conduct, analysis, or reporting of this study.
Competing interests JMT, JK, and CC have received support from the Sight and Life Institute, Center for Human Nutrition, Johns Hopkins Bloomberg School of Public Health. The institute was established with a gift from Task Force Sight and Life, Roche.
Ethical approval: This study was approved by the Aravind Eye and Children's Hospitals, the Department of Health, Tamil Nadu state government, and the Committee on Human Research of the Johns Hopkins Bloomberg School of Public Health.