Vitamin D DeficiencyEarly Phase 1NCT02091219
Effects of Vitamin D3 Versus 25OHD3 on Mineral Metabolism and Immune Function
A Early Phase 1 study testing Vitamin D and 25(OH)D3 in people with Vitamin D Deficiency, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D and 25(OH)D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to 7 Dec 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- 25D < 20 mg/ml
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCLA Clinical and Translational Research Center (CTRC)
Los Angeles, California, 90095
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D, 25(OH)D3
- Keywords
- Hypovitaminosis D, Free 25-hydroxyvitamin D, Total 25-hydroxyvitamin D
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Cholecalciferol
2400 IU/day by mouth for 16 weeks
25(OH)D3Drug
Also called Calcifediol, HyD
20 micrograms/day by mouth for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| 25(OH)D3 | Experimental | 20 micrograms/day by mouth for 16 weeks Receives: Drug: 25(OH)D3 |
| Vitamin D3 | Experimental | 2,400 IU/day by mouth for 16 weeks Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total serum 25D
Measured: 16 weeks
Secondary outcomes (8)
Change in serum free 25D
Measured: 16 weeks
Change in serum total 1,25D
Measured: 16 weeks
Change in total free 1,25D
Measured: 16 weeks
Change in serum calcium
Measured: 16 weeks
Change in urinary calcium
Measured: 16 weeks
Change in serum iPTH
Measured: 16 weeks
Change in serum bone turnover markers
Measured: 16 weeks
Change in markers of immune function
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2019
- Study completion7 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, John Adams, M.D., University of California, Los Angeles
- Investigators
- John S Adams, MD, Principal investigator, University of California, Los Angeles Department of Orhtopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091219
- Sponsor's protocol ID
- UL1TR000124-1954
- Other IDs
- 1P50AR063020-01, UL1TR000124
- Status last verified
- Apr 2021
- First submitted
- 12 Mar 2014
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Shieh A, Lee SM, Lagishetty V, Gottleib C, Jacobs JP, Adams JS. Pilot Trial of Vitamin D3 and Calcifediol in Healthy Vitamin D Deficient Adults: Does It Change the Fecal Microbiome? J Clin Endocrinol Metab. 2021 Nov 19;106(12):3464-3476. doi: 10.1210/clinem/dgab573.
PubMed 34343292Shieh A, Ma C, Chun RF, Wittwer-Schegg J, Swinkels L, Huijs T, Wang J, Donangelo I, Hewison M, Adams JS. Associations Between Change in Total and Free 25-Hydroxyvitamin D With 24,25-Dihydroxyvitamin D and Parathyroid Hormone. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3368-3375. doi: 10.1210/jc.2018-00515.
PubMed 29931358
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vitamin D3 Versus 25OHD3 (HyD) on Serum Vitamin D Metabolites and Markers of Mineral Metabolism and Immune Function
- ClinicalTrials.gov ID
- NCT02091219
- Acronym / sponsor ID
- UL1TR000124-1954
- Conditions
- Vitamin D Deficiency
- Keywords
- Hypovitaminosis D, Free 25-hydroxyvitamin D, Total 25-hydroxyvitamin D
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jun 2014
- Primary completion
- Dec 2019 (actual)
- Study completion
- 7 Dec 2019 (actual)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25(OH)D3 | Experimental | Drug: 25(OH)D320 micrograms/day by mouth for 16 weeks |
| Vitamin D3 | Experimental | Drug: Vitamin D2,400 IU/day by mouth for 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18
- 25D < 20 mg/ml
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: Cholecalciferol2400 IU/day by mouth for 16 weeks | Drug | Vitamin D3 |
| 25(OH)D3Also: Calcifediol, HyD20 micrograms/day by mouth for 16 weeks | Drug | 25(OH)D3 |
Primary outcome
Change in total serum 25D
Time frame: 16 weeks
8 secondary outcomes
Change in serum free 25D
Time frame: 16 weeks
Change in serum total 1,25D
Time frame: 16 weeks
Change in total free 1,25D
Time frame: 16 weeks
Change in serum calcium
Time frame: 16 weeks
Change in urinary calcium
Time frame: 16 weeks
Change in serum iPTH
Time frame: 16 weeks
Change in serum bone turnover markers
Time frame: 16 weeks
Change in markers of immune function
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 34343292Shieh A, Lee SM, Lagishetty V, Gottleib C, Jacobs JP, Adams JS. Pilot Trial of Vitamin D3 and Calcifediol in Healthy Vitamin D Deficient Adults: Does It Change the Fecal Microbiome? J Clin Endocrinol Metab. 2021 Nov 19;106(12):3464-3476. doi: 10.1210/clinem/dgab573.
- Derived from this study: PubMed 29931358Shieh A, Ma C, Chun RF, Wittwer-Schegg J, Swinkels L, Huijs T, Wang J, Donangelo I, Hewison M, Adams JS. Associations Between Change in Total and Free 25-Hydroxyvitamin D With 24,25-Dihydroxyvitamin D and Parathyroid Hormone. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3368-3375. doi: 10.1210/jc.2018-00515.
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John S Adams, MD principal investigator
University of California, Los Angeles Department of Orhtopaedic Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vitamin D and 25(OH)D3 in people with Vitamin D Deficiency, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total serum 25D (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02091219, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.