Effect of Different Vitamin D Vitamers on Vitamin D Status
VitD
1 other identifier
interventional
14
1 country
1
Brief Summary
Background: Dietary intake of vitamin D includes vitamin D3 (VitD3), 25-hydroxyvitamin D3 (25OHD3) and vitamin D2 (VitD2). However, the bioactivity of the different species is currently not scientifically established. Objective: The aim of this study was to test the hypothesis that VitD3, 25OHD3 and VitD2 affected vitamin D status equally in humans and if rejected, to estimate the difference in activity. Design: This study was designed as a 3 x 6 weeks (with 4 weeks run-in) double-blinded randomized cross-over study with 12 young, apparently healthy male volunteers and was performed during wintertime at 55 degree N. during the 4 weeks run-in period all volunteers received 10 ug/d VitD3 in order to achieve steady-state in vitamin D status. During the 3x6 weeks intervention periods the subjects received 10 ug/d VitD3, 10 ug/d 25OHD3 or 10 ug/d VitD2 in random order. Content of vitD3, VitD2, 25OHD3 and 25-hydroxyvitamin D2 (25OHD2) in serum were quantified my LC-MS/MS using 0.1 mL serum.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2007
Shorter than P25 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
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 19, 2016
CompletedFirst Posted
Study publicly available on registry
August 9, 2016
CompletedOctober 28, 2016
October 1, 2016
8 months
July 19, 2016
October 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Serum 25OHD
Vitamin D status after intervention with different types of vitamin D
1 year
Secondary Outcomes (2)
Serum Parathyreoideahormon
1 year
Serum Ca
1 year
Study Arms (3)
Vitamin D3
ACTIVE COMPARATOR10 ug/d of vitamin D3 for 6 weeks
Vitamin D2
ACTIVE COMPARATOR10 ug/d of vitamin D2 for 6 weeks
25OHD
ACTIVE COMPARATOR10 ug/ of 25OHD for 6 weeks
Interventions
Eligibility Criteria
You may qualify if:
- No drug use
- BMI\< 25 kg/m2
- Do not eat fish more than 2 x weekly
- Not donated blood within 3 months
- No Holiday plans in Winter 2006-2007
You may not qualify if:
- Any disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Nutrition, Exercise and Sports
Frederiksberg, 1958, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susanne Bügel
Department of Nutrition, Exercise and Sports
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
July 19, 2016
First Posted
August 9, 2016
Study Start
August 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
October 28, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share