Newborn Vitamin A (VA) Supplementation Pilot Project, Pakistan

NCT00674089 | Completed DMC

• 1 other identifier: 586-Ped/ERC-06
• Study Type: interventional
• Target: 7,400
• Locations: 1 country
• Sites: 1

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 advance in reaching the MDG 4 targets. This is thus persuasive reason to explore this particular preventive strategy, especially in terms of packaging with other postnatal care activities. However, given that in some instances it has been difficult to disentangle the effect of vitamin A dosing from concomitant vaccinations such as BCG, the current evidence needs further evaluation in effectiveness settings. We propose to evaluate the effectiveness of early neonatal vitamin A administration (single dose 50,000 units) to the newborn to see its effect on infant mortality less than 6 months of age as part of postnatal package through National Program. Government has launched the National Program for Family Planning and Primary Health Care since April 1994. Primarily it is being implemented in the community through Lady Health Workers (LHWs) of the National Program. The LHWs are females, with a minimum of eight years of education, residents of the locality in which they are working. The Programme is being currently implemented in all the districts throughout the country and 93,000 LHWs are working covering primarily women and children of the rural population. These LHWs deliver services related to family planning, maternal and child health, immunization, nutrition and treatment of minor ailments to her average registered population of 100-150 households or \~1000 population. Over 3,000 Supervisors have been recruited and trained to supervise the work of LHWs.

Conditions

Vitamin A Deficiency

Keywords

IMR; Newborn Mortality; Vitamin A Effectiveness; Premature Mortality; Mortality

Outcome Measures

Primary Outcomes (1)

• Primary outcome is reduction in Infant Mortality less than six months of age

  2 years

Secondary Outcomes (1)

• Secondary outcomes includes reduction in the incidence of diarrhea, ARI and Sepsis

  2 years

Study Arms (2)

1

ACTIVE COMPARATOR

Routine Post-partum Care and Vitamin A supplementation (50,000 IU) to the Newborn

Dietary Supplement: Vitamin A

2

PLACEBO COMPARATOR

Routine Post-partum Care with Placebo to the Newborn

Dietary Supplement: Placebo

Interventions

Vitamin A DIETARY_SUPPLEMENT

Vitamin A 50,000 IU

1

Placebo DIETARY_SUPPLEMENT

Vitamin A Placebo

2

Eligibility Criteria

• Age: Up to 15 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Live born infants from all pregnancies within participating villages will be eligible for enrollment in this study.

You may not qualify if:

• Child born with congenital malformation
• Serious birth injury
• Neonates with birth asphyxia and serious infections
• Gestational age less than 32 weeks
• Birth weight less than 1500 gms
• Refusal by parents to participate

Sponsors & Collaborators

• Aga Khan University: lead
• John Snow, Inc.: collaborator
• Pakistan Ministry of Health: collaborator
• Save the Children: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

Project Office

Sukkur, Sindh, 75300, Pakistan

Location

Related Publications (1)

• Soofi S, Ariff S, Sadiq K, Habib A, Bhatti Z, Ahmad I, Hussain M, Ali N, Cousens S, Bhutta ZA. Evaluation of the uptake and impact of neonatal vitamin A supplementation delivered through the Lady Health Worker programme on neonatal and infant morbidity and mortality in rural Pakistan: an effectiveness trial. Arch Dis Child. 2017 Mar;102(3):216-223. doi: 10.1136/archdischild-2016-310542. Epub 2016 Jun 28.

  PMID: 27471856 DERIVED

MeSH Terms

Conditions

Vitamin A Deficiency

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 7, 2008
• Study Start: January 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 10, 2011

Record last verified: 2010-10

Locations

PA (1)