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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hope Weiler, McGill University
ClinicalTrials.gov Identifier:
NCT00846677
First received: February 17, 2009
Last updated: March 1, 2012
Last verified: March 2012
  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.

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846677

Locations
Canada, Quebec
Mary Emily Clinical Nutrition Research Unit
Sainte Anne de Bellevue, Quebec, Canada, H9X 3V9
Sponsors and Collaborators
McGill University
Investigators
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 April 17, 2014