NCT03537443: BONUSKids

Bone and Muscle Health in Kids

Completed NA Last updated 24 August 2020

What this trial tests

NA trial testing Cholecalciferol (vitamin D3) in Skeletal Disorder in 642 participants. Completed in 5 February 2020.

Timeline

21 October 2018

Primary endpoint
5 February 2020

5 February 2020

Quick facts

Lead sponsor	The Hospital for Sick Children
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	642
Start date	21 October 2018
Primary completion	5 February 2020
Estimated completion	5 February 2020
Sites	1 location across Bangladesh

Drugs / interventions tested

• Cholecalciferol (vitamin D3) — full drug profile →

Conditions studied

• Skeletal Disorder — all drugs for Skeletal Disorder →

Sponsor

The Hospital for Sick Children

Who can join

Adults 45 Months to 51 Months, any sex, with Skeletal Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   O'Callaghan KM, Shanta SS, Fariha F, Harrington J, et al · · 2022 · cited 14× · PMID 34849536 · DOI 10.1093/ajcn/nqab396
2. Estimation of skeletal muscle mass in 4-year-old children using the D₃-creatine dilution method.
   Sidiqi A, Fariha F, Shanta SS, Dasiewicz A, et al · · 2023 · cited 2× · PMID 37037953 · DOI 10.1038/s41390-023-02587-1
3. Serum 25-Hydroxyvitamin D and Intact Parathyroid Hormone as Functional Biomarkers of Bone Mass in Early Childhood.
   O'Callaghan KM, Funk C, Fariha F, Nagaria MH, et al · · 2025 · cited 1× · PMID 40139482 · DOI 10.1016/j.tjnut.2025.03.022
4. Associations of linear growth and weight gain in the first 2 years with bone mass at 4 years of age in children in Dhaka, Bangladesh.
   Gias M, Qamar H, Fariha F, Mahmud AA, et al · · 2024 · cited 1× · PMID 39575549 · DOI 10.1017/s1368980024002301
5. Relationships Between 25-Hydroxyvitamin D, Parathyroid Hormone, and Bone Mass in 4-Year-Old Children in Dhaka, Bangladesh
   · 2022