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Can Correction of Low Vitamin D Status in Infancy Program for a Leaner Body Composition?

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: NCT02563015
Recruitment Status : Active, not recruiting
First Posted : September 29, 2015
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Hope Weiler, McGill University

Brief Summary:
One in four infants are born with low amounts of vitamin D stored in their body. This study is designed to test whether improving vitamin D status quickly after birth helps infants to build muscle and to normalize growth. This is important since the investigators have noticed in previous work that infants with low vitamin D have higher body weight relative to body length later on and that those who develop very good stores quickly have a leaner body type. Therefore, in this study infants with low stores early after birth will be given either the regular amount of supplementation or a higher amount to more rapidly build up the vitamin stores in the body. Infants in both groups will be measured for muscle and fat mass at standardized ages during the first year of life and into the toddler years. The information will inform health care professionals and parents of the importance of establishing good vitamin D stores early in life. Vitamin D supplementation is a modifiable factor that is already recommended for all term born infants. Knowing how much is needed in infants born with low stores has not been tested in a controlled manner in Canada.

Condition or disease Intervention/treatment Phase
Healthy Vitamin D Deficiency Dietary Supplement: cholecalciferol Dietary Supplement: Reference 400 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Novel Functional Outcomes of Vitamin D in Infancy; Can Correction of Low Vitamin D Status Program for a Leaner Body Composition Phenotype?
Actual Study Start Date : March 7, 2016
Estimated Primary Completion Date : February 20, 2022
Estimated Study Completion Date : February 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Cholecalciferol 400
400 IU orally per day
Dietary Supplement: cholecalciferol
liquid drops
Other Name: vitamin D3

Experimental: Cholecalciferol 1000
1000 IU orally per day
Dietary Supplement: cholecalciferol
liquid drops
Other Name: vitamin D3

Active Comparator: Reference 400
400 IU orally per day
Dietary Supplement: Reference 400
liquid drops
Other Name: vitaminD3




Primary Outcome Measures :
  1. Lean mass [ Time Frame: 3 years ]
    Whole body lean mass


Secondary Outcome Measures :
  1. 25(OH)D [ Time Frame: 3 years ]
    Concentration of serum 25(OH)D



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Exclusion Criteria:

  • Preterm;
  • Small for gestational age;
  • Maternal smoking in pregnancy, diabetes, preeclampsia, celiac disease, inflammatory bowel disease and medications that impact vitamin D/mineral metabolism.

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): NCT02563015


Locations
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Canada, Quebec
Mary Emily Clinical Nutrition Research Unit
Sainte Anne de Bellevue, Quebec, Canada, H9X 2E3
Sponsors and Collaborators
McGill University
Investigators
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Principal Investigator: Hope Weiler, PhD. McGill University
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Responsible Party: Hope Weiler, Associate Professor, McGill University
ClinicalTrials.gov Identifier: NCT02563015    
Other Study ID Numbers: HW-15-01
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hope Weiler, McGill University:
Infant
Vitamin D
Deficiency
Lean Mass
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents