Clinical Trial: Newborn Vitamin A (VA) Supplementation Pilot Project, Pakistan
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of the Effectiveness of Vitamin A Supplementation (VAS) as Part of a Neonatal Post Partum Care Package in Rural Pakistan
Brief Summary:
Vitamin A is an essential micronutrient for the normal functioning of the visual system, growth and development, immunity and reproduction. Its deficiency causes anemia, growth retardation and xerophthalmia. Vitamin A deficiency also increases the incidence and/or severity of infectious episodes and affects child survival. Reduced child survival is the most severe and potentially the most widespread consequence of Vitamin A deficiency. Improvement in vitamin A status is now regarded as one of the most cost effective preventive measures for the reduction of child mortality and morbidity.
Over the past decade several studies have examined the effect of vitamin A on reducing mortality among children aged ≥6months at the time of intervention. Impact of vitamin A supplementation can significantly reduce total mortality but it is only established through supplementation programs in children age 6 months or older. It was assumed that breast milk protects infants from vitamin A deficiency, but recent evidence has challenged this. Infants born with low stores of vitamin A and if the mother breast milk has a low concentration of vitamin A, as found in developing countries, the infants might be unable to meet their daily requirements and improve body reserves. There is association between mortality and degree of vitamin A deficiency, greater the degree of deficiency, higher the mortality.
The role of vitamin A in child survival is now well established and over 60 countries have vitamin A supplementation programs nationally. However, most are still using vitamin A supplements in the second half of infancy, even though over 75% of all under 5 deaths take place in the first 6 months of life. If neonatal vitamin A supplementation can be found to be effective and a service delivery mechanism also found, this will represent a major a
Detailed Summary:
Goal:
To reduce the infant mortality rate in rural Pakistan through evidence based interventions.
Aim:
To evaluate the impact of a community-based neonatal Vitamin A supplementation program on the morbidity and mortality in newborns and young infants (1-6 months of age) when administered at community level
Primary objectives:
- To evaluate the effectiveness of a single dose 50,000 IU of vitamin A supplementation to newborn infants within 48 hours after birth in rural Punjab and Sindh in reducing mortality (<6 months of age) by ≥ 25%.
- To evaluate the feasibility of neonatal vitamin A dosing when administered by LHW as part of postnatal care package
Methodology:
Study Design: Community based, cluster randomized, double blinded, placebo control trial
Sample size estimation:
Assuming average infant mortality rate 40 per thousand live births in the proposed clusters without intervention (range 30-50/1000 live births), and a targeted 25% reduction in mortality in first six months of life, (5% significance level and 80% power) our estimates indicate that the trial will require total 360 clusters [180 in each arm]. The average population size and birth rate per LHW are 1000 and 30 respectively Study Site: Districts Sukkhur and Jehlum. Both the districts, represent a typical mix of peri-urban and rural, multiethnic population of Pakistan. Although a public health care infrastructure exists, it is notable that
Sponsor: Aga Khan University
Current Primary Outcome: Primary outcome is reduction in Infant Mortality less than six months of age [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Secondary outcomes includes reduction in the incidence of diarrhea, ARI and Sepsis [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Aga Khan University
Dates:
Date Received: May 6, 2008
Date Started: January 2007
Date Completion:
Last Updated: August 9, 2011
Last Verified: October 2010
