Bone and Muscle Health in Kids (NCT03537443) | Clinical Trial Compass
CompletedNot Applicable
Bone and Muscle Health in Kids
Bangladesh642 participantsStarted 2018-10-21
Plain-language 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.
Who can participate
Age range
45 Months – 51 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total-body-less head bone mineral content and total-body-less head bone mineral density