Bone and Muscle Health in Kids (BONUSKids)
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|ClinicalTrials.gov Identifier: NCT03537443|
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : June 27, 2019
|Condition or disease|
Vitamin D is a modifiable regulator of bone mineral metabolism and muscle function; yet little is known about the role of in utero vitamin D exposure on bone mineral accrual and muscle development in early childhood. Observational findings suggest associations between prenatal vitamin D status and infant bone, lean and fat mass and muscle function, but data from intervention trials is either unavailable or limited to early infancy. The investigators of the proposed study have previously shown that prenatal vitamin D supplementation safely improves maternal-fetal vitamin D status and perinatal calcium metabolism. Given the current interest in the potential role of vitamin D in perinatal health, adequately powered and well-designed randomized trials are required to investigate the effect of maternal vitamin D supplementation on offspring musculoskeletal health and body composition.
The investigators recently conducted the Maternal Vitamin D for Infant Growth (MDIG) trial (NCT01924013), a randomized placebo-controlled dose-ranging trial of vitamin D supplementation in pregnancy and lactation in Bangladesh, where severe vitamin D deficiency is common. Women at 17-24 weeks' gestation were randomized to 1 of 5 dose groups (range 0-28,000 IU/wk) until 6 months postpartum. Enrolment (n=1300) was completed in September 2015, and all infants were delivered by February 2016. The MDIG trial was primarily designed to determine the effect of maternal vitamin D on infant length at 12 months of age, with follow-up continuing until infants reached 24 months of age (completed in March 2018).
In the proposed observational follow-up study, the investigators will leverage the design and infrastructure of the MDIG trial to investigate effects of vitamin D on early childhood bone and muscle outcomes in a sample of MDIG participants at 4 years of age (n=600). The primary objective is to quantify the effects of prenatal vitamin D supplementation versus placebo on offspring bone mineral content and density. Secondary objectives are to examine the effect of vitamin D on lean and fat mass, and muscle function. Bone, lean and fat mass will be measured using dual-energy x-ray absorptiometry (DXA). Muscle strength (handgrip test), anthropometry, dietary intake and vitamin D status will also be assessed, in addition to biomarkers of bone turnover that may affect musculoskeletal health in young children.
The proposed follow-up study of a large randomized trial will contribute new evidence regarding the effects of vitamin D supplementation during pregnancy on musculoskeletal health in childhood.
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official 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.|
|Actual Study Start Date :||October 21, 2018|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||March 31, 2020|
- Bone mineral content and bone mineral density [ Time Frame: 4 years of age ]
- Muscle function (handgrip strength) [ Time Frame: 4 years of age ]
- Lean and fat mass [ Time Frame: 4 years of age ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537443
|Contact: Daniel Roth, MD||(416) email@example.com|
|International Center for Diarrheal Disease Research||Recruiting|
|Contact: Abdullah Al Mahmud +8802-9840523-32 ext 3807 firstname.lastname@example.org|
|Principal Investigator:||Daniel Roth, MD||The Hospital for Sick Children|