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Study Comparing Two Vitamin D Supplements for Infants: Liquid Versus D-Strips

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: NCT00846677
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : March 2, 2012
Information provided by (Responsible Party):
Hope Weiler, McGill University

Brief Summary:

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 or disease Intervention/treatment Phase
Healthy Dietary Supplement: Vitamin D, cholecalciferol Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Randomized, Open-label, Cross-over Study Comparing Two Vitamin D Supplements for Infants: Liquid Versus D-Strips.
Study Start Date : January 2009
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Parental and infant preference for a new vitamin D delivery system over the standard of care supplement in syrup form. [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Barriers to either supplement delivery system being given during infancy. [ Time Frame: 21 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
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.

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): NCT00846677

Canada, Quebec
Mary Emily Clinical Nutrition Research Unit
Sainte Anne de Bellevue, Quebec, Canada, H9X 3V9
Sponsors and Collaborators
McGill University
Principal Investigator: Hope A Weiler, PhD McGill University

Responsible Party: Hope Weiler, Associate Professor, McGill University Identifier: NCT00846677     History of Changes
Other Study ID Numbers: PLB-D301
First Posted: February 19, 2009    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:
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents