Effects of Vitamin D Insufficiency in Man
1 other identifier
interventional
300
1 country
1
Brief Summary
We would like to determine if vitamin D insufficiency exists in different ethnic groups, if it has an effect on bone mass and muscle function, if it has an impact on the function of the cells of the immune system, and if the functioning level of these systems can be improved by stabilizing the vitamin D levels to within normal limits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2010
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
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 2, 2013
CompletedFirst Posted
Study publicly available on registry
May 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedMarch 3, 2020
February 1, 2020
9.5 years
May 2, 2013
February 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in serum 25D
5 weeks
Secondary Outcomes (8)
Change in bone mineral density by biochemistry
5 weeks
Change in muscle strength by exam
5 weeks
Change in muscle strength by questionnaire
5 weeks
Change in bone mineral density by DXA scan
5 weeks
Change in fractional urinary calcium:creatinine excretion ratio
5 weeks
- +3 more secondary outcomes
Study Arms (2)
Vitamin D2
EXPERIMENTALTotal of 500,000 IU vitamin D2 (50,000 IU twice weekly for 5 weeks)
Vitamin D3
EXPERIMENTALTotal of 500,000 IU vitamin D3 (50,000 IU twice weekly for 5 weeks)
Interventions
Eligibility Criteria
You may qualify if:
- D levels \<30 ng/ml (Vitamin D sufficient) OR \<20 ng/ml (Vitamin D deficient)
- At least 18 years of age
You may not qualify if:
- Hypercalcemia
- Hyperparathyroidism
- Hyperthyroidism
- Hypercalciuria
- Renal disease
- Intestinal malabsorption any disorder that places the subject at risk for developing hypercalcemia or hypercalciuria during standard vitamin D replacement therapy owing to the presence of underlying dysregulated vitamin D metabolism (e.g., sarcoidosis, TB, etc)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA
Los Angeles, California, 90095, United States
Related Publications (1)
Shieh A, Chun RF, Ma C, Witzel S, Meyer B, Rafison B, Swinkels L, Huijs T, Pepkowitz S, Holmquist B, Hewison M, Adams JS. Effects of High-Dose Vitamin D2 Versus D3 on Total and Free 25-Hydroxyvitamin D and Markers of Calcium Balance. J Clin Endocrinol Metab. 2016 Aug;101(8):3070-8. doi: 10.1210/jc.2016-1871. Epub 2016 May 18.
PMID: 27192696DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John S Adams, MD
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 2, 2013
First Posted
May 7, 2013
Study Start
August 1, 2010
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
March 3, 2020
Record last verified: 2020-02