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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hope Weiler, McGill University
ClinicalTrials.gov Identifier:
NCT00381914
First received: September 27, 2006
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Vitamin D Deficiency
Drug: Vitamin D
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Dose-Response Study to Establish Dietary Requirements in Infants

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • Vitamin D plasma concentrations [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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:
  • Bone mineral content [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 132
Study Start Date: March 2007
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 5 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381914

Locations
Canada, Quebec
Mary Emily Clinical Nutrition Research Unit
Sainte Anne de Bellevue, Quebec, Canada, H9X 2E3
Sponsors and Collaborators
McGill University
Investigators
Principal Investigator: Hope A Weiler, PhD McGill University
Principal Investigator: Celia Rodd, MD Montreal Children's Hospital of the MUHC
  More Information

No publications provided by McGill University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hope Weiler, Associate Professor, McGill University
ClinicalTrials.gov Identifier: NCT00381914     History of Changes
Other Study ID Numbers: HW-06-01
Study First Received: September 27, 2006
Last Updated: March 1, 2012
Health Authority: Canada: Health Canada

Keywords provided by McGill University:
Infants
Vitamin D
Dose-response

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014