Neonatal Vitamin A SupplementationNCT01138449
Efficacy of Newborn Vitamin A Supplementation Versus Placebo in Improving Child Survival (NeoVitA Trial)
A study testing Vitamin A in people with Neonatal Vitamin A Supplementation, run by Society for Applied Studies at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Neonatal Vitamin A Supplementation
- What is being tested?
- Vitamin A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44,984 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Consent to participate
- All births in the study area that are contacted by enrolment team within the eligible age window
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Society for Applied Studies
New Delhi, National Capital Territory of Delhi, 110016
About this study
Official title: Efficacy of Neonatal Vitamin A Supplementation in Improving Child Survival in Haryana, India: Generation of Evidence Necessary for Informing Global Policy
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.
Read the 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
- Being tested
- Vitamin A
- Keywords
- Vitamin A, Neonatal mortality, Infant mortality
- Medical subject headings
- Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADrug
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 group | Role | What they receive |
|---|---|---|
| Vitamin A | Experimental | Vitamin A capsules have retinol palmitate (50,000 IU) and minute amounts of vitamin E in soybean oil Receives: Drug: Vitamin A |
| Placebo | Placebo comparator | Placebo capsules contain minute amounts of vitamin E in soybean oil Receives: Drug: Vitamin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Period between receiving the intervention/placebo and six months of age
Secondary outcomes (5)
Risk of death
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).
Measured: Period between receiving the intervention/placebo and 28 days of age
Risk of death
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.
Measured: Period between receiving the intervention/placebo and 12 months of age
Risk of hospital admission
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.
Measured: 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
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
Measured: Three day period following supplementation
Vitamin A status in a subgroup of newborns and caregivers in the intervention and placebo groups
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
Measured: Two weeks and three months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neonatal Vitamin A SupplementationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44,984 participants (actual)
Sponsor and investigators
- Lead sponsor
- Society for Applied Studies
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, NBhandari, Society for Applied Studies
- Investigators
- Nita Bhandari, MD, PhD, Principal investigator, Society for Applied StudiesSunita Taneja, MD, PhD, Principal investigator, Society for Applied StudiesSarmila Mazumder, MD, PhD, Principal investigator, Society for Applied Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138449
- Sponsor's protocol ID
- RPC356
- Other IDs
- UTRN 112336978-06032010834860
- Status last verified
- May 2015
- First submitted
- 4 Jun 2010
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22361251Mazumder 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.
PubMed 25499546Upadhyay 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.
PubMed 29934384
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Neonatal Vitamin A Supplementation in Improving Child Survival in Haryana, India: Generation of Evidence Necessary for Informing Global Policy
- ClinicalTrials.gov ID
- NCT01138449
- Acronym / sponsor ID
- RPC356
- Conditions
- Neonatal Vitamin A Supplementation
- Keywords
- Vitamin A, Neonatal mortality, Infant mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44,984 participants (actual)
- Lead sponsor
- Society for Applied StudiesUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- Jun 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin A | Experimental | Drug: Vitamin AVitamin A capsules have retinol palmitate (50,000 IU) and minute amounts of vitamin E in soybean oil |
| Placebo | Placebo comparator | Drug: Vitamin APlacebo capsules contain minute amounts of vitamin E in soybean oil |
Who may qualify
- Ages
- 2 to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Consent to participate
- All births in the study area that are contacted by enrolment team within the eligible age window
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin ARetinol 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 | Drug | Placebo, Vitamin A |
Primary outcome
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.
5 secondary outcomes
Risk of death
Time frame: Period between receiving the intervention/placebo and 28 days of age
Risk of death
Time frame: Period between receiving the intervention/placebo and 12 months of age
Risk of hospital admission
Time frame: 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
Time frame: Three day period following supplementation
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Background: PubMed 22361251NEOVITA 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.
- Results publication: PubMed 25499546Mazumder 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.
- Derived from this study: PubMed 29934384Upadhyay 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.
Related trials for Neonatal Vitamin A Supplementation
Not yet recruiting
The OK Daily Study
Infant Vitamin K Status, Vitamin K Deficiency Bleeding
Not yet recruitingPhase 1
High-Dose Vitamin C in G6PDA and Pyruvate Kinase Deficiency: A Safety Study
Pyruvate Kinase Deficiency, Glucose 6 Phosphate Dehydrogenase Deficiency
Enrolling by invitation
Efficacy of Higher Dose Enteral Vitamin D Supplementation in Preterm 28 - 34 Weeks of Gestational Age
Vitamin D Supplementation
Not yet recruiting
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.
Vitamin D Deficiency, Osteopenia of Prematurity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nita Bhandari, MD, PhD principal investigator
Society for Applied Studies
Sunita Taneja, MD, PhD principal investigator
Society for Applied Studies
Sarmila Mazumder, MD, PhD principal investigator
Society for Applied Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin A in people with Neonatal Vitamin A Supplementation, run by Society for Applied Studies at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of death (time frame: Period between receiving the intervention/placebo and six months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01138449, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2015.