Safety and Bioefficacy of Vitamin D2 and Vitamin D3
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively, and by total 25(OH)D.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2012
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedFirst Posted
Study publicly available on registry
January 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedOctober 10, 2012
October 1, 2012
4 months
October 24, 2011
October 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change of 25-hydroxvitamin D
after 4 and 8 weeks of supplementation
Study Arms (3)
cholecalciferol
EXPERIMENTALHuman volunteers receiving cholecalciferol (vitamin D3) for 8 weeks
Ergocalciferol
EXPERIMENTALErgocalciferol 2000 IU per day for 8 weeks
Placebo
PLACEBO COMPARATORPlacebo for 8 weeks
Interventions
cholecalciferol, 2000 IU per day, 8 weeks
Eligibility Criteria
You may qualify if:
- years
- healthy
You may not qualify if:
- supplementation of vitamin d and calcium
- hypercalcemia
- hypercalciuria
- chronical illness (diabetes, kidney diseases, cardiovascular diseases)
- serum-creatinine above 115 mmol/l
- pregnancy or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ulrike Lehmannlead
Related Publications (1)
Lehmann U, Hirche F, Stangl GI, Hinz K, Westphal S, Dierkes J. Bioavailability of vitamin D(2) and D(3) in healthy volunteers, a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2013 Nov;98(11):4339-45. doi: 10.1210/jc.2012-4287. Epub 2013 Sep 3.
PMID: 24001747DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jutta Dierkes, Prof. Dr.
Institut für Agrar- und Ernährungswissenschaften
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 24, 2011
First Posted
January 2, 2012
Study Start
January 1, 2012
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
October 10, 2012
Record last verified: 2012-10