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

April 26, 2021 updated by: John Adams, M.D., University of California, Los Angeles

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
      • Los Angeles, California, United States, 90095
        • UCLA Clinical and Translational Research Center (CTRC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 25(OH)D3
20 micrograms/day by mouth for 16 weeks
Drug: 25(OH)D3
20 micrograms/day by mouth for 16 weeks
Other Names:
  • Calcifediol
  • HyD
Experimental: Vitamin D3
2,400 IU/day by mouth for 16 weeks
Drug: Vitamin D
2400 IU/day by mouth for 16 weeks
Other Names:
  • Cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in total serum 25D
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in serum free 25D
Time Frame: 16 weeks
16 weeks
Change in serum total 1,25D
Time Frame: 16 weeks
16 weeks
Change in total free 1,25D
Time Frame: 16 weeks
16 weeks
Change in serum calcium
Time Frame: 16 weeks
16 weeks
Change in urinary calcium
Time Frame: 16 weeks
16 weeks
Change in serum iPTH
Time Frame: 16 weeks
16 weeks
Change in serum bone turnover markers
Time Frame: 16 weeks
16 weeks
Change in markers of immune function
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: John S Adams, MD, University of California, Los Angeles Department of Orhtopaedic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 7, 2019

Study Registration Dates

First Submitted

March 12, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (Estimate)

March 19, 2014

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UL1TR000124-1954
  • UL1TR000124 (U.S. NIH Grant/Contract)
  • 1P50AR063020-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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