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Efficacy of Newborn Vitamin A Supplementation Versus Placebo in Improving Child Survival (NeoVitA Trial)

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ClinicalTrials.gov Identifier: NCT01138449
Recruitment Status : Completed
First Posted : June 7, 2010
Last Update Posted : June 1, 2015
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
NBhandari, Society for Applied Studies

Tracking Information
First Submitted Date  ICMJE June 4, 2010
First Posted Date  ICMJE June 7, 2010
Last Update Posted Date June 1, 2015
Study Start Date  ICMJE June 2010
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2010)
Risk of death [ Time Frame: Period between receiving the intervention/placebo and six months of age ]
To determine if vitamin A supplementation (50,000 IU) given to neonates once orally either on the day of birth or in the next 2 days will reduce mortality in the first half of infancy as compared to placebo.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2010)
  • Risk of death [ Time Frame: Period between receiving the intervention/placebo and 28 days of age ]
    To determine the efficacy of vitamin A supplementation (50,000 IU) given to neonates once orally either on the day of birth or in the next 2 days in reducing mortality in the neonatal period (first month of life).
  • Risk of death [ Time Frame: Period between receiving the intervention/placebo and 12 months of age ]
    To determine the efficacy of vitamin A supplementation (50,000 IU) given to neonates once orally either on the day of birth or in the next 2 days in reducing mortality at 12 months.
  • Risk of hospital admission [ Time Frame: Period between receiving the intervention/placebo and six months of age ]
    To determine the efficacy of the above intervention in reducing the incidence of severe morbidity defined as hospitalizations due to any illness in the first 6 months of infancy.
  • Bulging fontanelle, vomiting, irritability, fever, diarrhea, inability to suck or feed, convulsions or any other conditions that caused parents to be concerned [ Time Frame: Three day period following supplementation ]
    To assess bulging fontanelle, vomiting, irritability, fever, diarrhea, inability to suck or feed, convulsions or any other conditions that caused parents to be concerned, in the 3 day period following administration of the supplement
  • Vitamin A status in a subgroup of newborns and caregivers in the intervention and placebo groups [ Time Frame: Two weeks and three months of age ]
    To determine vitamin A status in a subsample of infants and caregivers in the intervention and placebo groups at 2 weeks and 3 months of age in the vitamin A supplementation and placebo groups
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2010)
  • Risk of death [ Time Frame: Period between receiving the intervention/placebo and 28 days of age ]
    To determine the efficacy of vitamin A supplementation (50,000 IU) given to neonates once orally either on the day of birth or in the next 2 days in reducing mortality in the neonatal period (first month of life).
  • Risk of hospital admission [ Time Frame: Period between receiving the intervention/placebo and six months of age ]
    To determine the efficacy of the above intervention in reducing the incidence of severe morbidity defined as hospitalizations due to any illness in the first 6 months of infancy.
  • Bulging fontanelle, vomiting, irritability, fever, diarrhea, inability to suck or feed, convulsions or any other conditions that caused parents to be concerned [ Time Frame: Three day period following supplementation ]
    To assess bulging fontanelle, vomiting, irritability, fever, diarrhea, inability to suck or feed, convulsions or any other conditions that caused parents to be concerned, in the 3 day period following administration of the supplement.
  • Vitamin A status in a subgroup of newborns and caregivers in the intervention and placebo groups [ Time Frame: Two weeks and three months of age ]
    To determine vitamin A status in a subsample of infants and caregivers in the intervention and placebo groups at 2 weeks and 3 months of age in the vitamin A supplementation and placebo groups
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Newborn Vitamin A Supplementation Versus Placebo in Improving Child Survival (NeoVitA Trial)
Official Title  ICMJE Efficacy of Neonatal Vitamin A Supplementation in Improving Child Survival in Haryana, India: Generation of Evidence Necessary for Informing Global Policy
Brief Summary The study is a large randomized controlled trial to assess the efficacy and safety of neonatal vitamin A supplementation administered to neonates once orally either on the day of birth or in the next 2 days in improving infant survival in the first 6 months of life.
Detailed Description

The study is an individually randomized trial conducted in two districts in the state of Haryana.

Community informants report births to the enrolment team. At enrolment, the team explains the study to the family and in those willing, written consent is obtained from the parents of the infant. The infant is given the dose of vitamin A/placebo and a form containing baseline socioeconomic characteristics and information on feeding practices of the infant and mother is filled.

After enrollment, each infant is visited by the enrollment team at hospital or home 1 day and 3 days after supplementation to document any illnesses in the baby. Newborns with illnesses are referred/escorted to the nearest health facility for management.

Enrolled infants are visited when aged 29 days, 3, 6 and 12 months to document vital status and hospitalizations since the last visit. Information on feeding practices, immunization, maternal intake of vitamin A rich foods and supplements, and intake of any supplement containing vitamin A by the infant is recorded at these visits. Subgroup analyses includes the effect of vitamin A supplementation in LBW and non LBW infants, male and female infants, immunized and unimmunized infants, infants of families in the poorest and richest quintiles and by vitamin A intake of mothers. For all deaths, verbal autopsy interviews are conducted.

Blood specimens are obtained in a subsample of infants at 2 weeks and 3 months of age and in a subsample of mothers at 3 months of age.

Quality control activities include independent and supervised checks and are conducted for a subsample by a separate team.

A DSMB has been constituted for the study. All deaths occurring within 72 hours of supplementation will be reported to the SAS ERC and to the WHO Coordinating Unit.

At the recent DSMB meeting in February 2012, the DSMB recommended an increase in sample size to 45,000 instead of the earlier estimate of 40,200 because of somewhat lower than expected mortality rates. This increase in sample size is expected to preserve the specified power of 0.85 and the corresponding level of precision anticipated at the design stage.

Similar trials are being funded by the World Health Organization (Geneva) in Ghana and Tanzania.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Neonatal Vitamin A Supplementation
Intervention  ICMJE Drug: Vitamin A
Retinol palmitate (50,000 IU) and minute amounts of vitamin E in soybean oil, orally as a single dose to neonates on the day of birth or in the next 2 days of birth keeping a minimum period of 2 hours between the birth and the dosing
Study Arms  ICMJE
  • Experimental: Vitamin A
    Vitamin A capsules have retinol palmitate (50,000 IU) and minute amounts of vitamin E in soybean oil
    Intervention: Drug: Vitamin A
  • Placebo Comparator: Placebo
    Placebo capsules contain minute amounts of vitamin E in soybean oil
    Intervention: Drug: Vitamin A
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2015)
44984
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2010)
40200
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Consent to participate
  • All births in the study area that are contacted by enrolment team within the eligible age window

Exclusion Criteria:

  • Unable to feed on offering feeds, as reported by the mother
  • Mother does not intend to stay in the study area for at least 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 72 Hours   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01138449
Other Study ID Numbers  ICMJE RPC356
UTRN 112336978-06032010834860 ( Registry Identifier: Clinical Trial Registry-India )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NBhandari, Society for Applied Studies
Study Sponsor  ICMJE Society for Applied Studies
Collaborators  ICMJE World Health Organization
Investigators  ICMJE
Principal Investigator: Nita Bhandari, MD, PhD Society for Applied Studies
Principal Investigator: Sunita Taneja, MD, PhD Society for Applied Studies
Principal Investigator: Sarmila Mazumder, MD, PhD Society for Applied Studies
PRS Account Society for Applied Studies
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP