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Bone and Muscle Health in Kids (BONUSKids)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537443
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : August 24, 2020
Sponsor:
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Daniel Roth, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Skeletal Disorder Dietary Supplement: Cholecalciferol (vitamin D3) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 642 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Primary Completion Date : February 5, 2020
Actual Study Completion Date : February 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Placebo Comparator: Group A (Placebo)
Children whose mothers were randomized to receive a weekly dose of placebo from 17-24 weeks of gestation to 26 weeks postpartum.
Dietary Supplement: Cholecalciferol (vitamin D3)
Prenatal and postpartum supplementation with vitamin D3 and/or placebo.

Experimental: Group B (4200:0 IU/week)
Children whose mothers were randomized to receive a prenatal:postpartum regimen of 4200 IU/week vitamin D3 from 17-24 weeks of gestation to delivery, followed by placebo from delivery to 26 weeks postpartum.
Dietary Supplement: Cholecalciferol (vitamin D3)
Prenatal and postpartum supplementation with vitamin D3 and/or placebo.

Experimental: Group C (16800:0 IU/week)
Children whose mothers were randomized to receive a prenatal:postpartum regimen of 16800 IU/week vitamin D3 from 17-24 weeks of gestation to delivery, followed by placebo from delivery to 26 weeks postpartum.
Dietary Supplement: Cholecalciferol (vitamin D3)
Prenatal and postpartum supplementation with vitamin D3 and/or placebo.

Experimental: Group D (28000:0 IU/week)
Children whose mothers were randomized to receive a prenatal:postpartum regimen of 28000 IU/week vitamin D3 from 17-24 weeks of gestation to delivery, followed by placebo from delivery to 26 weeks postpartum.
Dietary Supplement: Cholecalciferol (vitamin D3)
Prenatal and postpartum supplementation with vitamin D3 and/or placebo.

Experimental: Group E (28000:28000 IU/week)
Children whose mothers were randomized to receive a prenatal:postpartum regimen of 28000 IU/week vitamin D3 from 17-24 weeks of gestation to delivery, followed by the same dose (28000 IU/week vitamin D3) from delivery to 26 weeks postpartum.
Dietary Supplement: Cholecalciferol (vitamin D3)
Prenatal and postpartum supplementation with vitamin D3 and/or placebo.




Primary Outcome Measures :
  1. Total-body-less head bone mineral content and total-body-less head bone mineral density [ Time Frame: 4 years of age ]
    Measured by DXA


Secondary Outcome Measures :
  1. Muscle function (handgrip strength) [ Time Frame: 4 years of age ]
    Measured by hand-held dynamometer

  2. Total-body-less head lean and total-body-less head fat mass [ Time Frame: 4 years of age ]
    Measured by DXA

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

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

  5. Whole-body lean and whole-body fat mass [ Time Frame: 4 years of age ]
    Measured by DXA



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Ages Eligible for Study:   45 Months to 51 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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Bangladesh
International Center for Diarrheal Disease Research
Dhaka, Bangladesh
Sponsors and Collaborators
The Hospital for Sick Children
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
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Principal Investigator: Daniel Roth, MD The Hospital for Sick Children
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Responsible Party: Daniel Roth, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03537443    
Other Study ID Numbers: 1000060961
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Roth, The Hospital for Sick Children:
Childhood
Vitamin D
Bone mineral density
Bone mineral content
Additional relevant MeSH terms:
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Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents