CClinicalTrials.gg
CompletedNCT00674089VAUpdated Aug 10, 2011

Newborn Vitamin A (VA) Supplementation Pilot Project, Pakistan

An interventional study of Vitamin A and Placebo in Vitamin A Deficiency, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Open to participants aged Up to 15 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-10.

Sponsored by Aga Khan University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
7,400
Allocation
Randomized
Ages
Up to 15 Days
Sex
All
01

Study 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.

Read the detailed description

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:

  1. 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%.
  2. 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 almost 60% of the population seeks care from private health sector. Current rates of immunizations are poor (approximately 60%) and largely population is illiterate.

02

Conditions studied

  • Vitamin A Deficiency

Keywords

  • IMR
  • Newborn Mortality
  • Vitamin A Effectiveness
  • Premature Mortality
  • Mortality
03

In context

Night Blindness

58 studies on the registry are indexed under Night Blindness; 2 are open to participants now.

This study's enrollment of 7,400 is above the median of 155 across 42 interventional studies indexed under Night Blindness.

Browse Night Blindness studies →

Lead sponsor

Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 15 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
7,400 participants (actual)

Study arms

  • Active comparator
    1

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

    Dietary Supplement: Vitamin A

  • Placebo comparator
    2

    Routine Post-partum Care with Placebo to the Newborn

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementVitamin A

    Vitamin A 50,000 IU

  • Dietary supplementPlacebo

    Vitamin A Placebo

06

What researchers measure

Primary outcomes

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

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 2 years

07

Study locations

1 site
  • Project Office
    Sukkur, Sindh 75300, Pakistan
08

References and documents

Publications

  • 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. PubMed 27471856 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00674089
Lead sponsor
Aga Khan University
Collaborators
John Snow, Inc., Pakistan Ministry of Health, Save the Children, London School of Hygiene and Tropical Medicine
First posted
May 7, 2008
Start date
Jan 2007
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Aug 10, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion