Trial record 3 of 45 for:    Open Studies | "Vitamin A"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Society for Applied Studies.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
NBhandari, Society for Applied Studies
ClinicalTrials.gov Identifier:
NCT01138449
First received: June 4, 2010
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Neonatal Vitamin A Supplementation
Drug: Vitamin A

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Neonatal Vitamin A Supplementation in Improving Child Survival in Haryana, India: Generation of Evidence Necessary for Informing Global Policy

Resource links provided by NLM:


Further study details as provided by Society for Applied Studies:

Primary Outcome Measures:
  • Risk of death [ Time Frame: Period between receiving the intervention/placebo and six months of age ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Risk of death [ Time Frame: Period between receiving the intervention/placebo and 28 days of age ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 45000
Study Start Date: June 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin A
Vitamin A capsules have retinol palmitate (50,000 IU) and minute amounts of vitamin E in soybean oil
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
Placebo Comparator: Placebo
Placebo capsules contain minute amounts of vitamin E in soybean oil
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

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.

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138449

Contacts
Contact: Nita Bhandari, MD, PhD 00 91 11 46043751-55 ext 201 CHRD@sas.org.in
Contact: Sunita Taneja, MD, PhD 00 91 11 46043751-55 ext 301 CHRD@sas.org.in

Locations
India
Society for Applied Studies Recruiting
New Delhi, Delhi, India, 110016
Contact: Nita Bhandari, MD, PhD    00 91 11 46043751-55 ext 201    CHRD@sas.org.in   
Contact: Sunita Taneja, MD, PhD    00 91 11 46043751-55 ext 301    CHRD@sas.org.in   
Principal Investigator: Nita Bhandari, MD, PhD         
Principal Investigator: Sunita Taneja, MD, PhD         
Principal Investigator: Sarmila Mazumder, MD, PhD         
Sponsors and Collaborators
Society for Applied Studies
World Health Organization
Investigators
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
  More Information

No publications provided by Society for Applied Studies

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NBhandari, Director, Society for Applied Studies
ClinicalTrials.gov Identifier: NCT01138449     History of Changes
Other Study ID Numbers: RPC356, UTRN 112336978-06032010834860
Study First Received: June 4, 2010
Last Updated: April 2, 2012
Health Authority: United Nations: World Health Organization

Keywords provided by Society for Applied Studies:
Vitamin A
Neonatal mortality
Infant mortality

Additional relevant MeSH terms:
Vitamin A
Retinol palmitate
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014