Prevention of Vitamin D Deficiency
1 other identifier
interventional
398
1 country
1
Brief Summary
Breastfed infants living in a northern location (41 degrees N) are at high risk of vitamin D deficiency during winter. This trial is designed to determine how much supplemental vitamin D breastfed infants need to receive in order to remain free of vitamin D deficiency
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 28, 2007
CompletedFirst Posted
Study publicly available on registry
June 29, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedDecember 18, 2012
September 1, 2006
5 years
June 28, 2007
December 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase
end of winter
Secondary Outcomes (1)
whole body mineral content by DEXA
end of winter
Study Arms (4)
200 IU/day Vitamin D
ACTIVE COMPARATOR200 IU/day Vitamin D
400 IU/day Vitamin D
EXPERIMENTAL400 IU/day Vitamin D
600 IU/day Vitamin D
EXPERIMENTAL600 IU/day Vitamin D
800 IU/day Vitamin D
EXPERIMENTAL800 IU/day Vitamin D
Interventions
Infants receive daily 0.5 ml of code labeled supplement
Eligibility Criteria
You may qualify if:
- Term infant
- No major congenital malformations
- Less than one month old
- Breastfed, no other foods
You may not qualify if:
- Formula feeding
- Premature birth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MTF, 2501 Crosspark Rd
Coralville, Iowa, 52241-8802, United States
Related Publications (1)
Ziegler EE, Nelson SE, Jeter JM. Vitamin D supplementation of breastfed infants: a randomized dose-response trial. Pediatr Res. 2014 Aug;76(2):177-83. doi: 10.1038/pr.2014.76. Epub 2014 May 23.
PMID: 24858141DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ekhard Ziegler, MD
University of Iowa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2007
First Posted
June 29, 2007
Study Start
September 1, 2006
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
December 18, 2012
Record last verified: 2006-09