Bone and Muscle Health in Kids

NCT03537443 | Completed

• 1 other identifier: 1000060961
• Study Type: interventional
• Target: 642
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Childhood; Vitamin D; Bone mineral density; Bone mineral content

Outcome Measures

Primary Outcomes (1)

• Total-body-less head bone mineral content and total-body-less head bone mineral density

  Measured by DXA

  4 years of age

Secondary Outcomes (5)

• Muscle function (handgrip strength)

  4 years of age

• Total-body-less head lean and total-body-less head fat mass

  4 years of age

• Whole-body (including head) bone mineral content and whole-body bone mineral density

  4 years of age

• Head bone mineral content and head bone mineral density

  4 years of age

• Whole-body lean and whole-body fat mass

  4 years of age

Study Arms (5)

Group A (Placebo)

PLACEBO COMPARATOR

Children whose mothers were randomized to receive a weekly dose of placebo from 17-24 weeks of gestation to 26 weeks postpartum.

Dietary Supplement: Cholecalciferol (vitamin D3)

Group B (4200:0 IU/week)

EXPERIMENTAL

Children whose mothers were randomized to receive a prenatal:postpartum regimen of 4200 IU/week vitamin D3 from 17-24 weeks of gestation to delivery, followed by placebo from delivery to 26 weeks postpartum.

Dietary Supplement: Cholecalciferol (vitamin D3)

Group C (16800:0 IU/week)

EXPERIMENTAL

Children whose mothers were randomized to receive a prenatal:postpartum regimen of 16800 IU/week vitamin D3 from 17-24 weeks of gestation to delivery, followed by placebo from delivery to 26 weeks postpartum.

Dietary Supplement: Cholecalciferol (vitamin D3)

Group D (28000:0 IU/week)

EXPERIMENTAL

Children whose mothers were randomized to receive a prenatal:postpartum regimen of 28000 IU/week vitamin D3 from 17-24 weeks of gestation to delivery, followed by placebo from delivery to 26 weeks postpartum.

Dietary Supplement: Cholecalciferol (vitamin D3)

Group E (28000:28000 IU/week)

EXPERIMENTAL

Children whose mothers were randomized to receive a prenatal:postpartum regimen of 28000 IU/week vitamin D3 from 17-24 weeks of gestation to delivery, followed by the same dose (28000 IU/week vitamin D3) from delivery to 26 weeks postpartum.

Dietary Supplement: Cholecalciferol (vitamin D3)

Interventions

Cholecalciferol (vitamin D3) DIETARY_SUPPLEMENT

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

Group A (Placebo); Group B (4200:0 IU/week); Group C (16800:0 IU/week); Group D (28000:0 IU/week); Group E (28000:28000 IU/week)

Eligibility Criteria

• Age: 45 Months - 51 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The sample population will be drawn from a cohort registry of mother-infant pairs who participated in the recently-completed Maternal Vitamin D for Infant Growth (MDIG) randomized controlled trial (NCT01924013):
• Child is available for participation at 45 to 51 months postnatal age
• Mother received ≥80% of assigned prenatal vitamin D or placebo doses during the MDIG trial
• Child and primary caregiver(s) reside in Dhaka, Bangladesh or nearby regions
• A parent/guardian provides written or thumb-print informed consent for study procedures

You may not qualify if:

• Mother participated in the MDIG trial but chose not to be included in the cohort registry for contact regarding follow-up studies
• Children outside the eligible age range (aged below 45 months or above 51 months)
• Child is diagnosed with any developmental disorder that would render difficulty in completion of the DXA scan (e.g. Autism)
• Child is unable to bear weight on his/her legs (e.g. wheelchair bound)
• Child has a current fracture or break in which his/her limb is supported by an orthopedic cast

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

Study Sites (1)

International Center for Diarrheal Disease Research

Dhaka, Bangladesh

Location

Related Publications (2)

• O'Callaghan KM, Funk C, Fariha F, Nagaria MH, Dasiewicz A, Harrington J, Mahmud AA, Abrams SA, Ahmed T, Moore DR, Roth DE. Serum 25-Hydroxyvitamin D and Intact Parathyroid Hormone as Functional Biomarkers of Bone Mass in Early Childhood. J Nutr. 2025 Jun;155(6):1782-1794. doi: 10.1016/j.tjnut.2025.03.022. Epub 2025 Mar 24.

  PMID: 40139482 DERIVED

• O'Callaghan KM, Shanta SS, Fariha F, Harrington J, Mahmud AA, Emdin AL, Gernand AD, Ahmed T, Abrams SA, Moore DR, Roth DE. Effect of maternal prenatal and postpartum vitamin D supplementation on offspring bone mass and muscle strength in early childhood: follow-up of a randomized controlled trial. Am J Clin Nutr. 2022 Mar 4;115(3):770-780. doi: 10.1093/ajcn/nqab396.

  PMID: 34849536 DERIVED

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Daniel Roth, MD

  The Hospital for Sick Children

  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: Staff Physician

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: October 21, 2018
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: August 24, 2020

Record last verified: 2020-08

Locations

BA (1)