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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 October 2021 |
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Main ID: |
NCT02563015 |
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Date of registration:
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28/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Can Correction of Low Vitamin D Status in Infancy Program for a Leaner Body Composition?
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Scientific title:
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Novel Functional Outcomes of Vitamin D in Infancy; Can Correction of Low Vitamin D Status Program for a Leaner Body Composition Phenotype? |
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Date of first enrolment:
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March 7, 2016 |
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Target sample size:
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139 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02563015 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Hope Weiler, PhD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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McGill University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Term;
- Healthy;
- Appropriate weight for gestational age;
- Infants born to mothers with otherwise healthy pregnancy and free of medications that
impact vitamin D metabolism (except vitamin/mineral supplements) or fetal growth and
intent to breastfeed to at least 3 months;
- Infants born to mothers with gestational diabetes (screened for vitamin D status at
birth and randomized to 400 or 1000 IU/d vitamin D under an ancillary arm of this
study following the same protocol).
Exclusion Criteria:
- Preterm;
- Small for gestational age;
- Maternal smoking in pregnancy, diabetes (types 1 or 2), preeclampsia, celiac disease,
inflammatory bowel disease and medications that impact vitamin D/mineral metabolism.
Age minimum:
N/A
Age maximum:
1 Week
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gestational Diabetes
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Vitamin D Deficiency
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Healthy
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Intervention(s)
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Dietary Supplement: cholecalciferol
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Dietary Supplement: Reference 400
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Primary Outcome(s)
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Lean mass
[Time Frame: 3 years]
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Secondary Outcome(s)
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25(OH)D
[Time Frame: 3 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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