Bone and Muscle Health in Kids

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03537443
• Date of registration: 15/05/2018
• Prospective Registration: Yes
• Primary sponsor: The Hospital for Sick Children
• Public title: Bone and Muscle Health in Kids BONUSKids
• Scientific title: Effect of Maternal Vitamin D Supplementation During Pregnancy on Offspring Bone Mass, Body Composition and Muscle Strength in Early Childhood: Follow-up of a Randomized Controlled Trial Cohort.
• Date of first enrolment: October 21, 2018
• Target sample size: 642
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03537443
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Bangladesh

Contacts

• Name: Daniel Roth, MD
• Affiliation: The Hospital for Sick Children

Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

- 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



Age minimum: 45 Months
Age maximum: 51 Months
Gender: All

Health Condition(s) or Problem(s) studied

Skeletal Disorder

Intervention(s)

Dietary Supplement: Cholecalciferol (vitamin D3)

Primary Outcome(s)

Total-body-less head bone mineral content and total-body-less head bone mineral density [Time Frame: 4 years of age]

Secondary Outcome(s)

Head bone mineral content and head bone mineral density [Time Frame: 4 years of age]

Total-body-less head lean and total-body-less head fat mass [Time Frame: 4 years of age]

Whole-body lean and whole-body fat mass [Time Frame: 4 years of age]

Muscle function (handgrip strength) [Time Frame: 4 years of age]

Whole-body (including head) bone mineral content and whole-body bone mineral density [Time Frame: 4 years of age]

Secondary ID(s)

1000060961

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

International Centre for Diarrhoeal Disease Research, Bangladesh