Effects of Vitamin D3 Versus 25OHD3 on Mineral Metabolism and Immune Function
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/13/2018 |
| Start Date: | June 2014 |
| End Date: | December 2019 |
| Contact: | John S Adams, MD |
| Email: | jsadams@mednet.ucla.edu |
| Phone: | (310) 825-5585 |
The Effects of Vitamin D3 Versus 25OHD3 (HyD) on Serum Vitamin D Metabolites and Markers of Mineral Metabolism and Immune Function
The purpose of this study is to compare the effects of two different forms of vitamin D
supplements (vitamin D3 and 25-hyrdroxyvitamin D3 [25(OH)D3]) on vitamin D levels in the
blood, and on markers of skeletal and immune health. This study is designed as a pilot study.
A multi-ethnic cohort of 48 patients will be included (12 Caucasian, 12 African American, 12
Hispanic/Latino, 12 Asian/Asian American). Potential study candidates will undergo a
screening visit during which a medical history will be taken, a physical exam performed, a
dietary questionnaire administered, and blood collected. The purpose of the screening visit
is to identify vitamin D-deficient (25-hydroxyvitamin D <20 ng/ml) individuals who are
candidates for vitamin D supplementation. Eligible patients will then be randomly assigned to
receive either vitamin D3 (2400 IU/day) or 25(OH)D3 (20 mcg/day) for 16 weeks. After
initiating supplementation, study patients will return for follow-up visits at weeks 4, 8,
and 16. At each visit, blood will be collected to assess vitamin D levels in the blood, as
well as markers of skeletal and immune function. Participation in this study will therefore
involve a total of 5 visits (1 screening visit, 1 randomization visit during which
participants will receive their study supplements, 3 follow-up visits). After all data is
collected, changes in vitamin D levels in the blood following supplementation with either
vitamin D3 versus 25(OH)D3 will be determined, and correlated to markers of calcium balance
and immune function. Knowledge gained from this study may have a significant impact on how
vitamin D status is defined, and how vitamin D repletion is administered.
supplements (vitamin D3 and 25-hyrdroxyvitamin D3 [25(OH)D3]) on vitamin D levels in the
blood, and on markers of skeletal and immune health. This study is designed as a pilot study.
A multi-ethnic cohort of 48 patients will be included (12 Caucasian, 12 African American, 12
Hispanic/Latino, 12 Asian/Asian American). Potential study candidates will undergo a
screening visit during which a medical history will be taken, a physical exam performed, a
dietary questionnaire administered, and blood collected. The purpose of the screening visit
is to identify vitamin D-deficient (25-hydroxyvitamin D <20 ng/ml) individuals who are
candidates for vitamin D supplementation. Eligible patients will then be randomly assigned to
receive either vitamin D3 (2400 IU/day) or 25(OH)D3 (20 mcg/day) for 16 weeks. After
initiating supplementation, study patients will return for follow-up visits at weeks 4, 8,
and 16. At each visit, blood will be collected to assess vitamin D levels in the blood, as
well as markers of skeletal and immune function. Participation in this study will therefore
involve a total of 5 visits (1 screening visit, 1 randomization visit during which
participants will receive their study supplements, 3 follow-up visits). After all data is
collected, changes in vitamin D levels in the blood following supplementation with either
vitamin D3 versus 25(OH)D3 will be determined, and correlated to markers of calcium balance
and immune function. Knowledge gained from this study may have a significant impact on how
vitamin D status is defined, and how vitamin D repletion is administered.
Inclusion Criteria:
- Age > 18
- 25D < 20 mg/ml
Exclusion Criteria:
- Age < 18
- 25D > 20 ng/ml at time of screening
- Clear signs of infection at time of screening (coughing, sneezing, wheezing,
frequency, dysuria)
- History of conditions that would influence intestinal absorption of vitamin D3 or
25OHD3 supplements
- History of nephrolithiasis, primary hyperparathyroidism, or other metabolic bone
disease
- History of chronic kidney disease (defined as CrCl < 30 ml/min)
- History of rheumatologic or autoimmune conditions
- History of sarcoidosis
- History of active or latent tuberculosis
- History of HIV
- History of hyperthyroidism
- History of chronic glucocorticoid use defined as the equivalent of 5 mg of prednisone
per day for more than 2 months within the last 6 months
- History of use of medications known to affect calcium/vitamin D metabolism, bone
metabolism, and immune response
- Hypercalcemia
- Hypercalcinuria
We found this trial at
2
sites
Los Angeles, California 90095
Principal Investigator: John S Adams, MD
Phone: 424-248-5617
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