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

NCT01138449 | Completed DMC

• 2 other identifiers: RPC356UTRN 112336978-06032010834860
• Study Type: interventional
• Target: 44,984
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Vitamin A Supplementation

Keywords

Vitamin A; Neonatal mortality; Infant mortality

Outcome Measures

Primary Outcomes (1)

• Risk of death

  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.

  Period between receiving the intervention/placebo and six months of age

Secondary Outcomes (5)

• Risk of death

  Period between receiving the intervention/placebo and 28 days of age

• Risk of death

  Period between receiving the intervention/placebo and 12 months of age

• Risk of hospital admission

  Period between receiving the intervention/placebo and six months of age

• Bulging fontanelle, vomiting, irritability, fever, diarrhea, inability to suck or feed, convulsions or any other conditions that caused parents to be concerned

  Three day period following supplementation

• Vitamin A status in a subgroup of newborns and caregivers in the intervention and placebo groups

  Two weeks and three months of age

Study Arms (2)

Vitamin A

EXPERIMENTAL

Vitamin A capsules have retinol palmitate (50,000 IU) and minute amounts of vitamin E in soybean oil

Drug: Vitamin A

Placebo

PLACEBO COMPARATOR

Placebo capsules contain minute amounts of vitamin E in soybean oil

Drug: Vitamin A

Interventions

Vitamin A DRUG

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; Vitamin A

Eligibility Criteria

• Age: 2 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Society for Applied Studies: lead
• World Health Organization: collaborator

Study Sites (1)

Society for Applied Studies

New Delhi, National Capital Territory of Delhi, 110016, India

Location

Related Publications (3)

• NEOVITA Study Author Group; Bahl R, Bhandari N, Dube B, Edmond K, Fawzi W, Fontaine O, Kaur J, Kirkwood BR, Martines J, Masanja H, Mazumder S, Msham S, Newton S, Oleary M, Ruben J, Shannon C, Smith E, Taneja S, Yoshida S. Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial. Trials. 2012 Feb 23;13:22. doi: 10.1186/1745-6215-13-22.

  PMID: 22361251 BACKGROUND

• Mazumder S, Taneja S, Bhatia K, Yoshida S, Kaur J, Dube B, Toteja GS, Bahl R, Fontaine O, Martines J, Bhandari N; Neovita India Study Group. Efficacy of early neonatal supplementation with vitamin A to reduce mortality in infancy in Haryana, India (Neovita): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Apr 4;385(9975):1333-42. doi: 10.1016/S0140-6736(14)60891-6. Epub 2014 Dec 11.

  PMID: 25499546 RESULT

• Upadhyay RP, Martines JC, Taneja S, Mazumder S, Bahl R, Bhandari N, Dalpath S, Bhan MK. Risk of postneonatal mortality, hospitalisation and suboptimal breast feeding practices in low birthweight infants from rural Haryana, India: findings from a secondary data analysis. BMJ Open. 2018 Jun 22;8(6):e020384. doi: 10.1136/bmjopen-2017-020384.

  PMID: 29934384 DERIVED

MeSH Terms

Conditions

Infant Death

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 7, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 1, 2015

Record last verified: 2015-05

Locations

IN (1)