- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00674089
Newborn Vitamin A (VA) Supplementation Pilot Project, Pakistan (VA)
Evaluation of the Effectiveness of Vitamin A Supplementation (VAS) as Part of a Neonatal Post Partum Care Package in Rural Pakistan
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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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 almost 60% of the population seeks care from private health sector. Current rates of immunizations are poor (approximately 60%) and largely population is illiterate.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sindh
-
Sukkur, Sindh, Pakistan, 75300
- Project Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Live born infants from all pregnancies within participating villages will be eligible for enrollment in this study.
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
Routine Post-partum Care and Vitamin A supplementation (50,000 IU) to the Newborn
|
Vitamin A 50,000 IU
|
PLACEBO_COMPARATOR: 2
Routine Post-partum Care with Placebo to the Newborn
|
Vitamin A Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Primary outcome is reduction in Infant Mortality less than six months of age
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary outcomes includes reduction in the incidence of diarrhea, ARI and Sepsis
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 586-Ped/ERC-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vitamin A Deficiency
-
SourseCitruslabsActive, not recruitingMood | Energy Supply; Deficiency | B12 Deficiency VitaminUnited States
-
Boston UniversityCompletedVitamin D Deficiency | Vitamin E Deficiency | Hypovitaminosis AUnited States
-
Quadram Institute BioscienceNorfolk and Norwich University Hospitals NHS Foundation TrustEnrolling by invitationIron Deficiency (Without Anemia) | B12 Deficiency VitaminUnited Kingdom
-
Kansas State UniversityNational Institute for Medical Research, Tanzania; United States Department... and other collaboratorsCompletedAnemia, Iron-Deficiency | Deficiency, Vitamin A
-
Newcastle UniversityBill and Melinda Gates Foundation; Institute of Nutrition of Central America... and other collaboratorsUnknownVitamin A Deficiency | Vitamin A Toxicity | Hypervitaminosis AGuatemala, United Kingdom
-
Fatih Sultan Mehmet Training and Research HospitalActive, not recruitingVitamin D Deficiency | Lipedema | B12 Deficiency VitaminTurkey
-
Nottingham University Hospitals NHS TrustNorthern Care Alliance NHS Foundation Trust; Barts & The London NHS Trust; University... and other collaboratorsNot yet recruitingParesthesia | Neurologic Symptoms | B12 Deficiency Vitamin | Nitrous Oxide Abuse | Subacute Combined Cord Degeneration
-
University of Wisconsin, MadisonNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedVitamin A Deficiency | Vitamin A ToxicityUnited States
-
University of California, DavisPenn State University; University of Ghana; Newcastle University; Helen Keller...CompletedAnemia | Dietary Habits | Iron Deficiency | Vitamin A Deficiency | Vitamin B 12 Deficiency | Folate Deficiency | Zinc DeficiencyGhana
Clinical Trials on Vitamin A
-
Ohio State University Comprehensive Cancer CenterRecruitingAllogeneic Hematopoietic Stem Cell Transplantation RecipientUnited States
-
Institut de Recherche pour le DeveloppementUniversity of Copenhagen; Thrasher Research Fund; National Institute of Nutrition...CompletedMaking Maternal Post-partum Vitamin A Supplementation Effective: The Role of Timing and InflammationHealthy Women Giving Birth to Singleton InfantsVietnam
-
Sheba Medical CenterNot yet recruitingThe Relationship Between Oral Vitamin A Administration and the Incidence of BPD in Preterm Infants Born Before Week 29 of Pregnancy
-
Tehran University of Medical SciencesUnknownAtherosclerosisIran, Islamic Republic of
-
Instituto Materno Infantil Prof. Fernando FigueiraCompletedVitamin A Deficiency | HypovitaminosisBrazil
-
Eunice Kennedy Shriver National Institute of Child...Unknown
-
University GhentFlemish Interuniversity Council (VLIR); Arba Minch University, EthiopiaCompletedVitamin A Deficiency | Anemia, Iron Deficiency | Cognitive Development | Helminthic InfectionEthiopia
-
Shiraz University of Medical SciencesNot yet recruiting
-
National Food Technology Research Centre, BotswanaNetherlands: Ministry of Health, Welfare and Sports; UNICEF; University of BotswanaUnknownAssessment of Vitamin A Status of Children
-
Medical Research Council, South AfricaUniversity of Wisconsin, Madison; International Atomic Energy AgencyCompletedHypervitaminosis ASouth Africa