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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01138449 |
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Date of registration:
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04/06/2010 |
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Primary sponsor: |
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Public title:
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Efficacy of Newborn Vitamin A Supplementation Versus Placebo in Improving Child Survival (NeoVitA Trial)
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Scientific title:
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Efficacy of Neonatal Vitamin A Supplementation in Improving Child Survival in Haryana, India: Generation of Evidence Necessary for Informing Global Policy |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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45000 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01138449 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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India
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Contacts
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Name:
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Nita Bhandari, MD, PhD |
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Address:
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Telephone:
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00 91 11 46043751-55 |
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Email:
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CHRD@sas.org.in |
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Affiliation:
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Name:
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Nita Bhandari, MD, PhD |
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Address:
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Telephone:
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00 91 11 46043751-55 |
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Email:
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CHRD@sas.org.in |
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Affiliation:
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Name:
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Nita Bhandari, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Society for Applied Studies |
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Name:
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Sarmila Mazumder, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Society for Applied Studies |
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Name:
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Sunita Taneja, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Society for Applied Studies |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
72 Hours
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neonatal Vitamin A Supplementation
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Intervention(s)
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Drug: Vitamin A
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Primary Outcome(s)
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Risk of death
[Time Frame: Period between receiving the intervention/placebo and six months of age]
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Secondary Outcome(s)
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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]
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Risk of death
[Time Frame: Period between receiving the intervention/placebo and 12 months of age]
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Risk of death
[Time Frame: Period between receiving the intervention/placebo and 28 days of age]
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Risk of hospital admission
[Time Frame: Period between receiving the intervention/placebo and six months of age]
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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]
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Secondary ID(s)
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RPC356
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UTRN 112336978-06032010834860
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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