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
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: 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 July 20, 2014