Study Comparing Two Vitamin D Supplements for Infants: Liquid Versus D-Strips
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Purpose
Vitamin D supplementation (400 IU/d) is recommended for all breastfed infants in Canada. Such recommendation is grounded in the fact that the prevalence of rickets in Canada is higher than desirable, likely due to low maternal-fetal transfer and low intakes postpartum.
There is little data about adherence to supplementation in Canada, but one study shows that in primiparous mothers (n=1937) in Quebec, 58.1 % of those exclusively breast-feeding gave their infant vitamin D supplements in the first six months and 62.1 % of those feeding formula did not. For the Canadian situation, it is not clear if the modality of the supplementation is a barrier to providing the supplement. Thus the overall aim of this study is to test a new delivery system for parental preference and infant acceptance compared to a standard vitamin D supplement.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Dietary Supplement: Vitamin D, cholecalciferol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | A Randomized, Open-label, Cross-over Study Comparing Two Vitamin D Supplements for Infants: Liquid Versus D-Strips. |
- Parental and infant preference for a new vitamin D delivery system over the standard of care supplement in syrup form. [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- Barriers to either supplement delivery system being given during infancy. [ Time Frame: 21 days ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | January 2009 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Vitamin D quick dissolve strip
|
Dietary Supplement: Vitamin D, cholecalciferol
Oral Quick Dissolve Strip, 400 IU once per day for 21 days
Other Name: BabyVita Vitamin D
|
|
Active Comparator: 2
Vitamin D syrup
|
Dietary Supplement: Vitamin D, cholecalciferol
Oral Syrup, 400IU per day for 21 days
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 4 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy singleton newborn infants born at term age of any racial background.
- Infants may be breastfed or formula fed during the study as is safe since the supplement is 400 IU/d and intakes from breast milk or formula will not exceed 400 IU/d for a theoretical total intake of 800 IU/d that is recommended by the Canadian Pediatric Society.
Exclusion Criteria:
- Infants born prematurely, twins or other multiples.
- Unable to nurse or accept the supplement.
- Congenital malformations.
- Parents not fluent enough in English or French to provide written informed consent.
Contacts and Locations| Canada, Quebec | |
| Mary Emily Clinical Nutrition Research Unit | |
| Sainte Anne de Bellevue, Quebec, Canada, H9X 3V9 | |
| Principal Investigator: | Hope A Weiler, PhD | McGill University |
More Information
No publications provided
| Responsible Party: | Hope Weiler, Associate Professor, McGill University |
| ClinicalTrials.gov Identifier: | NCT00846677 History of Changes |
| Other Study ID Numbers: | PLB-D301 |
| Study First Received: | February 17, 2009 |
| Last Updated: | March 1, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by McGill University:
|
Healthy Infants Vitamin D |
Additional relevant MeSH terms:
|
Cholecalciferol Vitamin D Ergocalciferols Vitamins Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on September 26, 2012
