Vitamin D DeficiencyNCT01688102
The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
A study testing Oral Vitamin D3 and Ultraviolet Light in people with Vitamin D Deficiency, run by Rockefeller University at 1 site in United States.
Trial summary
Participants in this study will be randomized to receive either oral vitamin D pills OR ultraviolet light treatment. The investigators will compare how these two methods of raising vitamin D levels will affect cholesterol levels. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Oral Vitamin D3 and Ultraviolet Light
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Vitamin D 25-OH level < 20 ng/ml
Who cannot join
- Serum calcium > 10.5 mg/dl
- Serum phosphorus > 5.5 mg/dl
- Serum parathyroid hormone (PTH) level < 12 pg/ml
- LDL cholesterol > 190 mg/dl
- History of recent acute infection (within 1 month)
- Glomerular filtration rate(GFR) < 60 mL/min
Show all 17Show fewer
- Liver Function tests indicative of liver disease (aspartate aminotransferase (AST) or alanine transferase (ALT) > 3x ULN)
- Current use of Vitamin D > 400 IU/day
- Current use of any statins, fibrates, niacin, or ezetimibe
- Current use of any medications affecting sensitivity to UV light
- Pregnancy (self-reported)
- Intentional UV exposure (e.g. tanning bed use) in the last 2 weeks or planned use while participating in the study
- history of malignancy not in remission (> 6 months)
- History of malignant melanoma
- Participation in an investigational drug study within 30 days of the screening visit
- Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
- History of any non-melanoma skin cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
Participants in this study will be randomized to receive either oral vitamin D pills OR ultraviolet light treatment. The investigators will compare how these two methods of raising vitamin D levels will affect cholesterol levels.
Read the detailed description
Potential subjects will be screened for eligibility, including serum 25(OH)D levels <20ng/ml. Eligible subjects will be randomly assigned to receive either: 1) oral vitamin D3, 50,000 units weekly for 8 weeks or 2) narrow-band UVB radiation, 2 treatments/wk for 8 weeks. Duration of treatment will be based on skin type. After 8 weeks, 25(OH)D levels will be measured monthly. For participants with levels <35 ng/ml, additional doses of oral vitamin D3 or UV radiation will be administered.
A subset of participants from both groups will participate in a skin biopsy cohort, where skin biopsies are obtained before and after 8 weeks of treatment.
- Conditions
- Vitamin D Deficiency
- Being tested
- Oral Vitamin D3, Ultraviolet Light
- 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.
Oral Vitamin D3Dietary supplement
50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed
Ultraviolet LightRadiation
16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Oral Vitamin D3 | Active comparator | Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D. Receives: Dietary Supplement: Oral Vitamin D3 |
| Ultraviolet Light | Active comparator | Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB. Receives: Radiation: Ultraviolet Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL Cholesterol Level
Measured: baseline and 6 months or last observation carried forward (minimum 2 months)
Secondary outcomes (7)
Change in Total Cholesterol
Change in Total Cholesterol
Measured: baseline and 6 months or last observation carried forward (minimum 2 months)
Change in HDL Cholesterol
Measured: baseline and 6 months or last observation carried forward (minimum 2 months)
Change in Triglycerides
Measured: baseline 6 months or last observation carried forward (minimum 2 months)
Change in C Reactive Protein
Measured: baseline and 6 months
Change in 25(OH)D
Measured: baseline vs. 6 months
Change in Serum Calcium
Measured: baseline vs. 6 months
Change in Parathyroid Hormone (PTH)
Measured: baseline vs.6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manish Ponda, Rockefeller University
- Investigators
- Manish Ponda, MD MS, Principal investigator, The Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688102
- Sponsor's protocol ID
- MPO-0787
- Status last verified
- Oct 2017
- First submitted
- 12 Sep 2012
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ponda MP, Liang Y, Kim J, Hutt R, Dowd K, Gilleaudeau P, Sullivan-Whalen MM, Rodrick T, Kim DJ, Barash I, Lowes MA, Breslow JL. A randomized clinical trial in vitamin D-deficient adults comparing replenishment with oral vitamin D3 with narrow-band UV type B light: effects on cholesterol and the transcriptional profiles of skin and blood. Am J Clin Nutr. 2017 May;105(5):1230-1238. doi: 10.3945/ajcn.116.150367. Epub 2017 Feb 22.
PubMed 28228421
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
- ClinicalTrials.gov ID
- NCT01688102
- Acronym / sponsor ID
- MPO-0787
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Posted 23 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants in this study will be randomized to receive either oral vitamin D pills OR ultraviolet light treatment. The investigators will compare how these two methods of raising vitamin D levels will affect cholesterol levels.
Detailed description
Potential subjects will be screened for eligibility, including serum 25(OH)D levels <20ng/ml. Eligible subjects will be randomly assigned to receive either: 1) oral vitamin D3, 50,000 units weekly for 8 weeks or 2) narrow-band UVB radiation, 2 treatments/wk for 8 weeks. Duration of treatment will be based on skin type. After 8 weeks, 25(OH)D levels will be measured monthly. For participants with levels <35 ng/ml, additional doses of oral vitamin D3 or UV radiation will be administered.
A subset of participants from both groups will participate in a skin biopsy cohort, where skin biopsies are obtained before and after 8 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Vitamin D3 | Active comparator | Dietary Supplement: Oral Vitamin D3Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D. |
| Ultraviolet Light | Active comparator | Radiation: Ultraviolet LightSubjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Vitamin D 25-OH level < 20 ng/ml
Key exclusion criteria (17 listed)
- Serum calcium > 10.5 mg/dl
- Serum phosphorus > 5.5 mg/dl
- Serum parathyroid hormone (PTH) level < 12 pg/ml
- LDL cholesterol > 190 mg/dl
- History of recent acute infection (within 1 month)
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 |
|---|---|---|
| Oral Vitamin D350,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed | Dietary supplement | Oral Vitamin D3 |
| Ultraviolet Light16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes | Radiation | Ultraviolet Light |
Primary outcome
Change in LDL Cholesterol Level
Time frame: baseline and 6 months or last observation carried forward (minimum 2 months)
7 secondary outcomes
Change in Total Cholesterol
Time frame: baseline and 6 months or last observation carried forward (minimum 2 months)
Change in HDL Cholesterol
Time frame: baseline and 6 months or last observation carried forward (minimum 2 months)
Change in Triglycerides
Time frame: baseline 6 months or last observation carried forward (minimum 2 months)
Change in C Reactive Protein
Time frame: baseline and 6 months
Change in 25(OH)D
Time frame: baseline vs. 6 months
Change in Serum Calcium
Time frame: baseline vs. 6 months
Change in Parathyroid Hormone (PTH)
Time frame: baseline vs.6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28228421Ponda MP, Liang Y, Kim J, Hutt R, Dowd K, Gilleaudeau P, Sullivan-Whalen MM, Rodrick T, Kim DJ, Barash I, Lowes MA, Breslow JL. A randomized clinical trial in vitamin D-deficient adults comparing replenishment with oral vitamin D3 with narrow-band UV type B light: effects on cholesterol and the transcriptional profiles of skin and blood. Am J Clin Nutr. 2017 May;105(5):1230-1238. doi: 10.3945/ajcn.116.150367. Epub 2017 Feb 22.
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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.
Manish Ponda, MD MS principal investigator
The Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Vitamin D3 and Ultraviolet Light in people with Vitamin D Deficiency, run by Rockefeller University at 1 site 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 17 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 LDL Cholesterol Level (time frame: baseline and 6 months or last observation carried forward (minimum 2 months)). 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 NCT01688102, which also lists 1 linked publication.
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 6 Nov 2017.