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Bone and Muscle Health in Kids

NCT03537443 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 642

Last updated 2020-08-24

No results posted yet for this study

Summary

Vitamin D deficiency in childhood leads to poor bone growth and muscle weakness, yet it is unknown if the amount of vitamin D a woman consumes during her pregnancy affects her child's bone and muscle development. In collaboration with researchers in Bangladesh, the investigators recently completed a study of vitamin D supplementation during pregnancy in which women were assigned to 1 of 5 groups containing vitamin D or placebo (no vitamin D). The investigators now aim to conduct a follow-up study of a sample of 600 4 year old children born to these mothers to test the possible effects of vitamin D supplementation in pregnancy on children's bones, their body composition and the strength of their muscles.

Conditions

  • Skeletal Disorder

Interventions

DIETARY_SUPPLEMENT

Cholecalciferol (vitamin D3)

Prenatal and postpartum supplementation with vitamin D3 and/or placebo.

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Daniel Roth, MD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Months
Max Age
51 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-21
Primary Completion
2020-02-05
Completion
2020-02-05

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03537443 on ClinicalTrials.gov