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Abstract
Background Despite evidence for the benefits of vitamin A supplementation (VAS) among children 6 to 59 months of age, the feasibility of introduction and potential benefit of VAS in the neonatal period in public health programmes is uncertain.
Objective The primary objective was to evaluate the feasibility and effectiveness of early neonatal VAS (single dose of 50 000 international units within 48–72 hours after birth) delivered through the public sector Lady Health Worker (LHW) programme in rural Pakistan and to document its association with a reduction in mortality at 6 months of age.
Methods A community-based, cluster randomised, placebo-controlled trial was undertaken in two districts of rural Pakistan. LHWs dispensed vitamin A/placebo in identical capsules to newborn infants within 48–72 hours of birth. Follow-up visits were undertaken at 1 week of age and every 4 weeks thereafter until 6 months of age.
Results Of a total of 15 433 consecutive pregnancies among eligible women of reproductive age, 13 225 pregnancies were registered, 12 218 live births identified and 11 028 newborn infants reached by LHWs. Of these, 5380 (49%) received neonatal VAS and 5648 (51%) placebo. The LHWs successfully delivered the capsules to 79% of newborns within 72 hours of birth with no significant adverse effects. Although the proportion of days observed with symptoms of fever, diarrhoea or rapid breathing were lower with neonatal VAS, these differences were not statistically significant. Mortality rates in the two groups were comparable at 6 months of age.
Conclusions While our study demonstrated that neonatal VAS was safe and could be feasibly delivered by LHWs in Pakistan as part of their early postnatal visits, the overall lack of benefit on neonatal and 6-month morbidity and mortality in our population suggests the need for further evaluation of this intervention in populations at risk.
Trial registration number ClinicalTrials.gov NCT00674089.
- Vitamin A Supplementation
- Lady Health Worker
- Neonatal Morbidity
- Neonatal Mortality
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Footnotes
Twitter Follow Kamran Sadiq at @sadiqkamran
Contributors ZAB conceived the study and as principal investigator was involved in all aspects of the study. SS was study coordinator and oversaw study implementation. SA and SS wrote the first draft and were responsible for subsequent and final versions of the manuscript. ZAB reviewed and finalised the final version. KS, AH and NA were involved in study design, analysis planning and interpretation of data. MH implemented the study at the field site. IA and ZB oversaw the data management, coordination and data cleaning. SC was involved in data analysis and interpretation of data. All authors reviewed and approved the final manuscript.
Funding This study was funded by PAIMAN (Pakistan Initiative for Mothers and Newborns)/John Snow Inc via a grant funded by USAID, Award Number: Sub-agreement #36098-01 (USAID cooperative agreement #391-A-00-05-01037-00). The funding body provided clearance for the project design but, apart from field visits to review progress, did not influence the field trial or the data analysis procedures.
Competing interests None declared.
Patient consent Obtained.
Ethics approval This study was approved by the Ethical Review Committee of Aga Khan University, Karachi, Pakistan. All the respondents gave informed consent prior to completing the interviews.
Provenance and peer review Not commissioned; externally peer reviewed.