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

NCT ID: NCT01138449

Last Updated: 2015-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44984 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-06-30

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.

Conditions

Neonatal Vitamin A Supplementation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin A

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

Group Type: EXPERIMENTAL

Vitamin A

Intervention Type: 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

Placebo capsules contain minute amounts of vitamin E in soybean oil

Group Type: PLACEBO_COMPARATOR

Vitamin A

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 2 Hours
• Maximum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

World Health Organization

OTHER

Sponsor Role: collaborator

Society for Applied Studies

OTHER

Sponsor Role: lead

Responsible Party

NBhandari

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nita Bhandari, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Society for Applied Studies

Sunita Taneja, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Society for Applied Studies

Sarmila Mazumder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Society for Applied Studies

Locations

Society for Applied Studies

New Delhi, National Capital Territory of Delhi, India

Countries

India

References

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.

Reference Type: BACKGROUND

PMID: 22361251 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25499546 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29934384 (View on PubMed)

Other Identifiers

UTRN 112336978-06032010834860

Identifier Type: REGISTRY

Identifier Source: secondary_id

RPC356

Identifier Type: -

Identifier Source: org_study_id