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Vitamin D Dose-Response Study to Establish Dietary Requirements in Infants

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. Identifier: NCT00381914
Recruitment Status : Completed
First Posted : September 28, 2006
Last Update Posted : March 2, 2012
Information provided by (Responsible Party):
Hope Weiler, McGill University

Brief Summary:
The research team is comprised of an expert nutrition scientist and a pediatrician with expertise in endocrinology. Both have world-class experience in assessing bone mass in infancy. Together they have designed a study to determine how much dietary vitamin D is needed to optimize health in infants. This is important since many infants are born with vitamin D deficiency. At present the dosage of vitamin D that is optimal for infant health is unclear and recent research suggests that vitamin D status very early in life has long lasting effects on bone mass and other health issues. Therefore, in a group of healthy infants, this research team will test which dosage of vitamin D is needed to achieve optimal vitamin D status. Optimal vitamin D status will be based on growth, biomarkers of vitamin D and bone status in blood and also general health. The infants will all be breastfed and begin the study at about 2 weeks of age. At 3 months intervals over the first year of life, each infant will be measured for growth, duration of breastfeeding and supplement use plus have a bone density scan to determine changes in bone growth. The data will be helpful to guide health care professionals in providing the best care possible for their infants. It will also be important to the health of populations since dietary recommendations for vitamin D are used to guide fortification of foods and development of evidence based policy around nutrient recommendations and their implementation.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: Vitamin D Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Dose-Response Study to Establish Dietary Requirements in Infants
Study Start Date : March 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: 1
400 IU / day vitamin D
Drug: Vitamin D
400 IU vitamin D / day

Experimental: 2
800 IU / day vitamin D
Drug: Vitamin D
800 IU vitamin D / day

Experimental: 3
1200 IU / day vitamin D
Drug: Vitamin D
1200 IU vitamin D / day

Primary Outcome Measures :
  1. Vitamin D plasma concentrations [ Time Frame: 12 months ]
    25(OH)D concentrations will me measured in infants over the first year of life. The blood sampling will be done at 1, 2, 3, 6, 9 and 12 months of age. Monitoring the vitamin D concentrations will allow the investigators to determine the best dose of vitamin D for breast fed infants receiving one of three vitamin D dosages.

Secondary Outcome Measures :
  1. Bone mineral content [ Time Frame: 12 months ]
    Bone mineral content will be assessed at 1, 3, 6, 9 and 12 months of age. Using DXA technology which provides measures of bone mineral content as well as body composition measurements the investigators will be able to correlate these changes with vitamin D concentrations.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy singleton term born infants of appropriate size for gestational age (AGA) according to the Centers for Disease Control growth charts based on weight at birth between the 5th and 95th percentiles for sex; and born to healthy breastfeeding women. This allows us to assess growth and bone mineral accretion without bias of intrauterine growth restriction.

Exclusion Criteria:

  • Infants of mothers with history of gestational diabetes or hypertension in pregnancy; chronic alcohol use; malabsorption syndromes due to malabsorption of vitamin D (celiac disease, Crohn's etc.); and multiple births.
  • Should any exclusion criteria be identified after recruitment, the infant will be excluded from the main analyzes, but followed in a separate arm as intent-to-treat.

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 identifier (NCT number): NCT00381914

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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
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Principal Investigator: Hope A Weiler, PhD McGill University
Principal Investigator: Celia Rodd, MD Montreal Children's Hospital of the MUHC
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hope Weiler, Associate Professor, McGill University Identifier: NCT00381914    
Other Study ID Numbers: HW-06-01
First Posted: September 28, 2006    Key Record Dates
Last Update Posted: March 2, 2012
Last Verified: March 2012
Keywords provided by Hope Weiler, McGill University:
Vitamin D
Additional relevant MeSH terms:
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Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents