MedDataX Logo

Effect of Vitamin D Supplementation on Health of Low Birth Weight Infants

NCT ID: NCT00415402

Last Updated: 2012-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether a weekly supplement of vitamin D to low birth weight term infants will reduce their mortality and hospital admissions and improve their immunity.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

We are conducting a randomised controlled trial of weekly oral vitamin D supplements to low birth weight (\< 2.5 kg) term infants born in a large government hospital catering to a low-middle income population in Delhi. Mothers and infants are recruited at delivery and given weekly vitamin D supplements or placebo until 6 months of age. Data on infant morbidity, sun exposure and diet, with particular emphasis on breast milk and other milk intake, is collected by fieldworkers visiting the homes each fortnight. Mothers are encouraged to bring their infants to the hospital in case of any illness and at these visits the infant is seen by the project doctor who treats the infant and records additional morbidity data. At 6 months blood samples are being collected from a 20% random subsample of infants for measurement of 25OHD and indicators of immune activation. The primary outcome is mortality or incidence of any illness requiring admission to hospital.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitamin D Deficiency

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Vitamin D3 morbidity mortality low birth weight supplementation TH1 TH2 CRP Neopterin immune response

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo

non vitamin D containing sugar granules

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Vitamin D3

vitamin D granules

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin D3

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Born at term, as determined from last menstrual period
* Weighing \< 2.5 kg
* Resident within 12 km of the hospital and expected to continue living in the area for the following 6 months
* With no severe congenital abnormalities
* No morbidity severe enough to be expected to result in death before 7 days due to severe respiratory distress, shock, pulmonary sepsis, etc.
* Parental informed consent
Minimum Eligible Age

24 Hours

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

Sitaram Bhartia Institute of Science and Research

OTHER

Sponsor Role collaborator

Delhi University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Geeta Trilok-Kumar

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Geeta Trilok-Kumar, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Home Economics, Delhi University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institute of Home Economics, Delhi University

New Delhi, , India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

References

Explore related publications, articles, or registry entries linked to this study.

Kumar GT, Sachdev HS, Chellani H, Rehman AM, Singh V, Arora H, Filteau S. Effect of weekly vitamin D supplements on mortality, morbidity, and growth of low birthweight term infants in India up to age 6 months: randomised controlled trial. BMJ. 2011 May 31;342:d2975. doi: 10.1136/bmj.d2975.

Reference Type RESULT
PMID: 21628364 (View on PubMed)

Trilok-Kumar G, Arora H, Rajput M, Chellani H, Singh V, Raynes J, Arya S, Aggarwal S, Srivastava N, Sachdev HP, Filteau S. Effect of vitamin D supplementation of low birth weight term Indian infants from birth on cytokine production at 6 months. Eur J Clin Nutr. 2012 Jun;66(6):746-50. doi: 10.1038/ejcn.2012.33. Epub 2012 Apr 18.

Reference Type RESULT
PMID: 22510791 (View on PubMed)

Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.

Reference Type DERIVED
PMID: 33305842 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IHE/VITD/2006

Identifier Type: -

Identifier Source: secondary_id

BT/PR 7489/PID/20/285/2006

Identifier Type: -

Identifier Source: org_study_id