NCT00415402

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

3.3 years

First QC Date

December 21, 2006

Last Update Submit

August 21, 2012

Conditions

Vitamin D Deficiency

Keywords

Vitamin D3morbiditymortalitylow birth weightsupplementationTH1TH2CRPNeopterinimmune response

Outcome Measures

Primary Outcomes (3)

  • Mortality

    weekly

  • Incidence of disease requiring hospitalization

  • Morbidity and hospitalization

    weekly

Secondary Outcomes (2)

  • Incidence of infectious disease not requiring hospitalization

  • Severe morbidity requiring hospitalization

Study Arms (2)

placebo

PLACEBO COMPARATOR

non vitamin D containing sugar granules

Vitamin D3

EXPERIMENTAL

vitamin D granules

Drug: Vitamin D3

Interventions

Vitamin D3DRUG
Vitamin D3

Eligibility Criteria

Age24 Hours - 2 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Home Economics, Delhi University

New Delhi, 110016, India

Location

Related Publications (3)

  • 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.

    PMID: 21628364RESULT

  • 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.

    PMID: 22510791RESULT

  • 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.

    PMID: 33305842DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Geeta Trilok-Kumar, PhD

    Institute of Home Economics, Delhi University

    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
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 22, 2006

Study Start

March 1, 2007

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations

IN(1)