Effects of Vitamin D3 Versus 25OHD3 on Mineral Metabolism and Immune Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-12-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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25(OH)D3

20 micrograms/day by mouth for 16 weeks

Group Type EXPERIMENTAL

25(OH)D3

Intervention Type DRUG

20 micrograms/day by mouth for 16 weeks

Vitamin D3

2,400 IU/day by mouth for 16 weeks

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

2400 IU/day by mouth for 16 weeks

Interventions

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Vitamin D

2400 IU/day by mouth for 16 weeks

Intervention Type DRUG

25(OH)D3

20 micrograms/day by mouth for 16 weeks

Intervention Type DRUG

Other Intervention Names

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Cholecalciferol Calcifediol HyD

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No