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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Vitamin D3 | Dietary Supplement | 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL Cholesterol Level | baseline and 6 months or last observation carried forward (minimum 2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Cholesterol | Change in Total Cholesterol | baseline and 6 months or last observation carried forward (minimum 2 months) |
| Change in HDL Cholesterol | baseline and 6 months or last observation carried forward (minimum 2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Change in LDL Cholesterol and Change in Calcium | The Correlation between change in LDL cholesterol and change in serum calcium | 2 months |
| Correlation Between Change in LDL Cholesterol and Change in PTH |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manish Ponda, MD MS | The Rockefeller University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Rockefeller University | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28228421 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Vitamin D3 | 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. Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed |
| FG001 | Ultraviolet Light | 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. Ultraviolet Light: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Vitamin D3 | 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. Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in LDL Cholesterol Level | Posted | Mean | Standard Deviation | mg/dl | baseline and 6 months or last observation carried forward (minimum 2 months) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Vitamin D3 | 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. Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin erythema/burn | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manish Ponda | The Rockefeller University | 212-327-7631 | mponda@rockefeller.edu |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D014466 | Ultraviolet Rays |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Ultraviolet Light | Radiation | 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 |
|
| Change in Triglycerides | baseline 6 months or last observation carried forward (minimum 2 months) |
| Change in C Reactive Protein | baseline and 6 months |
| Change in 25(OH)D | baseline vs. 6 months |
| Change in Serum Calcium | baseline vs. 6 months |
| Change in Parathyroid Hormone (PTH) | baseline vs.6 months |
| 2 months |
| Gene Expression Changes in Peripheral Blood | Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets. | baseline vs. 2 months |
| Gene Expression Changes in Skin | Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets. | baseline vs. 2 months |
| Ultraviolet Light |
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. Ultraviolet Light: 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Total Cholesterol | Change in Total Cholesterol | Posted | Mean | Standard Deviation | mg/dL | baseline and 6 months or last observation carried forward (minimum 2 months) |
|
|
|
| Secondary | Change in HDL Cholesterol | Posted | Mean | Standard Deviation | mg/dL | baseline and 6 months or last observation carried forward (minimum 2 months) |
|
|
|
| Secondary | Change in Triglycerides | Posted | Mean | Standard Deviation | mg/dL | baseline 6 months or last observation carried forward (minimum 2 months) |
|
|
|
| Secondary | Change in C Reactive Protein | Data analyzed are only for those who completed 6 months of therapy | Posted | Mean | Standard Deviation | mg/L | baseline and 6 months |
|
|
|
| Secondary | Change in 25(OH)D | Data only for those who completed 6 months of therapy | Posted | Mean | Standard Deviation | ng/ml | baseline vs. 6 months |
|
|
|
| Secondary | Change in Serum Calcium | Posted | Mean | Standard Deviation | mg/dL | baseline vs. 6 months |
|
|
|
| Secondary | Change in Parathyroid Hormone (PTH) | Posted | Mean | Standard Deviation | pg/mL | baseline vs.6 months |
|
|
|
| Other Pre-specified | Correlation Between Change in LDL Cholesterol and Change in Calcium | The Correlation between change in LDL cholesterol and change in serum calcium | Posted | Number | Pearson correlation coefficient | 2 months |
|
|
|
| Other Pre-specified | Correlation Between Change in LDL Cholesterol and Change in PTH | Posted | Number | Pearson correlation coefficient | 2 months |
|
|
|
| Other Pre-specified | Gene Expression Changes in Peripheral Blood | Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets. | Posted | Number | GSEA Normalized Enrichment Score | baseline vs. 2 months |
|
|
|
| Other Pre-specified | Gene Expression Changes in Skin | Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets. | Posted | Number | GSEA Normalized Enrichment Score | baseline vs. 2 months |
|
|
|
| 1 |
| 60 |
| 7 |
| 60 |
| EG001 | Ultraviolet Light | 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. Ultraviolet Light: 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 | 2 | 58 | 21 | 58 |
| Wound Infection | Infections and infestations |
|
| Hip Pain | Musculoskeletal and connective tissue disorders |
|
| GI Distress | Gastrointestinal disorders |
|
| Skin dryness/irritation | Skin and subcutaneous tissue disorders |
|
| Constipation/Hemmorhoids | Gastrointestinal disorders |
|
| Tooth infection | Infections and infestations |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D055620 | Optical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D011840 | Radiation, Nonionizing |
| D013472 | Sunlight |
| D014887 | Weather |
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |