Vitamin D Dose-Response Study to Establish Dietary Requirements in Infants
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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 |
- 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.
- 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 |
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| Canada, Quebec | |
| Mary Emily Clinical Nutrition Research Unit | |
| Sainte Anne de Bellevue, Quebec, Canada, H9X 2E3 | |
| Principal Investigator: | Hope A Weiler, PhD | McGill University |
| Principal Investigator: | Celia Rodd, MD | Montreal Children's Hospital |
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 Vitamin D Ergocalciferols |
Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013