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Trial record 2 of 7 for:    strength | ( Map: Bangladesh )

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
Sponsor:
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Daniel Roth, The Hospital for Sick Children

Tracking Information
First Submitted Date May 15, 2018
First Posted Date May 25, 2018
Last Update Posted Date June 27, 2019
Actual Study Start Date October 21, 2018
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 25, 2019)
Bone mineral content and bone mineral density [ Time Frame: 4 years of age ]
Original Primary Outcome Measures
 (submitted: May 15, 2018)
Bone mineral content and bone mineral density [ Time Frame: 3-4 years of age ]
Change History Complete list of historical versions of study NCT03537443 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 25, 2019)
  • Muscle function (handgrip strength) [ Time Frame: 4 years of age ]
  • Lean and fat mass [ Time Frame: 4 years of age ]
Original Secondary Outcome Measures
 (submitted: May 15, 2018)
  • Muscle function (handgrip strength) [ Time Frame: 3-4 years of age ]
  • Lean and fat mass [ Time Frame: 3-4 years of age ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bone and Muscle Health in Kids
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.
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.
Detailed Description

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum samples will be collected for analysis of 25-hydroxyvitamin D and related bone-turnover markers.
Sampling Method Non-Probability Sample
Study Population Children aged 4 years of age born to mothers who participated in the Maternal Vitamin D for Infant Growth (MDIG) randomized controlled trial (NCT01924013), who are living in Dhaka, Bangladesh.
Condition Skeletal Disorder
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 25, 2019)
600
Original Estimated Enrollment
 (submitted: May 15, 2018)
250
Estimated Study Completion Date March 31, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Months to 51 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Daniel Roth, MD (416) 813-5795 daniel.roth@sickkids.ca
Listed Location Countries Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number NCT03537443
Other Study ID Numbers VitaminD_Kids
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Daniel Roth, The Hospital for Sick Children
Study Sponsor The Hospital for Sick Children
Collaborators International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: Daniel Roth, MD The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date October 2018