Trial Outcomes & Findings for The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile (NCT NCT01688102)

NCT ID: NCT01688102

Last Updated: 2017-11-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 118 participants
• Primary outcome timeframe: baseline and 6 months or last observation carried forward (minimum 2 months)
• Results posted on: 2017-11-06

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	60	58
Overall Study COMPLETED	44	40
Overall Study NOT COMPLETED	16	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile

Baseline characteristics by cohort

Measure	Oral Vitamin D3 n=60 Participants 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	Ultraviolet Light n=58 Participants 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	Total n=118 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 12 • n=5 Participants	39 years STANDARD_DEVIATION 12 • n=7 Participants	42 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	58 participants n=7 Participants	118 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months or last observation carried forward (minimum 2 months)

Outcome measures

Measure	Oral Vitamin D3 n=60 Participants 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	Ultraviolet Light n=58 Participants 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
Change in LDL Cholesterol Level	3.2 mg/dl Standard Deviation 18.4	1.4 mg/dl Standard Deviation 17.8

SECONDARY outcome

Timeframe: baseline and 6 months or last observation carried forward (minimum 2 months)

Change in Total Cholesterol

Outcome measures

Measure	Oral Vitamin D3 n=60 Participants 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	Ultraviolet Light n=58 Participants 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
Change in Total Cholesterol	4.1 mg/dL Standard Deviation 22	2.0 mg/dL Standard Deviation 18.8

SECONDARY outcome

Timeframe: baseline and 6 months or last observation carried forward (minimum 2 months)

Outcome measures

Measure	Oral Vitamin D3 n=60 Participants 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	Ultraviolet Light n=58 Participants 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
Change in HDL Cholesterol	0.2 mg/dL Standard Deviation 8.1	0.3 mg/dL Standard Deviation 8.4

SECONDARY outcome

Timeframe: baseline 6 months or last observation carried forward (minimum 2 months)

Outcome measures

Measure	Oral Vitamin D3 n=60 Participants 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	Ultraviolet Light n=58 Participants 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
Change in Triglycerides	2.6 mg/dL Standard Deviation 35.4	1.7 mg/dL Standard Deviation 42.0

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Data analyzed are only for those who completed 6 months of therapy

Outcome measures

Measure	Oral Vitamin D3 n=44 Participants 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	Ultraviolet Light n=40 Participants 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
Change in C Reactive Protein	1.88 mg/L Standard Deviation 6.87	-.11 mg/L Standard Deviation 5.1

SECONDARY outcome

Timeframe: baseline vs. 6 months

Population: Data only for those who completed 6 months of therapy

Outcome measures

Measure	Oral Vitamin D3 n=44 Participants 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	Ultraviolet Light n=40 Participants 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
Change in 25(OH)D	18.7 ng/ml Standard Deviation 8.0	15.6 ng/ml Standard Deviation 8.2

SECONDARY outcome

Timeframe: baseline vs. 6 months

Outcome measures

Measure	Oral Vitamin D3 n=44 Participants 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	Ultraviolet Light n=40 Participants 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
Change in Serum Calcium	.09 mg/dL Standard Deviation .35	.07 mg/dL Standard Deviation .29

SECONDARY outcome

Timeframe: baseline vs.6 months

Outcome measures

Measure	Oral Vitamin D3 n=44 Participants 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	Ultraviolet Light n=40 Participants 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
Change in Parathyroid Hormone (PTH)	-5 pg/mL Standard Deviation 19	-9 pg/mL Standard Deviation 31

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 months

The Correlation between change in LDL cholesterol and change in serum calcium

Outcome measures

Measure	Oral Vitamin D3 n=60 Participants 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	Ultraviolet Light n=58 Participants 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
Correlation Between Change in LDL Cholesterol and Change in Calcium	0.24 Pearson correlation coefficient	.16 Pearson correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 months

Outcome measures

Measure	Oral Vitamin D3 n=60 Participants 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	Ultraviolet Light n=58 Participants 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
Correlation Between Change in LDL Cholesterol and Change in PTH	-.01 Pearson correlation coefficient	.18 Pearson correlation coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline vs. 2 months

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.

Outcome measures

Measure	Oral Vitamin D3 n=15 Participants 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	Ultraviolet Light n=13 Participants 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
Gene Expression Changes in Peripheral Blood Interferon-alpha response	4.14 GSEA Normalized Enrichment Score	-4.05 GSEA Normalized Enrichment Score
Gene Expression Changes in Peripheral Blood Interferon-gamma response	3.41 GSEA Normalized Enrichment Score	-4.86 GSEA Normalized Enrichment Score

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline vs. 2 months

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.

Outcome measures

Measure	Oral Vitamin D3 n=9 Participants 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	Ultraviolet Light n=7 Participants 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
Gene Expression Changes in Skin Interferon-alpha response	2.08 GSEA Normalized Enrichment Score	-2.43 GSEA Normalized Enrichment Score
Gene Expression Changes in Skin Interferon-gamma response	2.12 GSEA Normalized Enrichment Score	-2.00 GSEA Normalized Enrichment Score

Adverse Events

Oral Vitamin D3

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Ultraviolet Light

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Oral Vitamin D3 n=60 participants at risk 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	Ultraviolet Light n=58 participants at risk 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
Vascular disorders Hypertension	0.00% 0/60	1.7% 1/58 • Number of events 1
Infections and infestations Wound Infection	1.7% 1/60 • Number of events 1	0.00% 0/58
Musculoskeletal and connective tissue disorders Hip Pain	0.00% 0/60	1.7% 1/58 • Number of events 1

Other adverse events

Measure	Oral Vitamin D3 n=60 participants at risk 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	Ultraviolet Light n=58 participants at risk 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
Skin and subcutaneous tissue disorders Skin erythema/burn	0.00% 0/60	20.7% 12/58 • Number of events 15
Gastrointestinal disorders GI Distress	10.0% 6/60 • Number of events 9	3.4% 2/58 • Number of events 2
Skin and subcutaneous tissue disorders Skin dryness/irritation	1.7% 1/60 • Number of events 3	13.8% 8/58 • Number of events 9
Gastrointestinal disorders Constipation/Hemmorhoids	6.7% 4/60 • Number of events 4	1.7% 1/58 • Number of events 1
Infections and infestations Tooth infection	3.3% 2/60 • Number of events 2	5.2% 3/58 • Number of events 3

Additional Information

Dr. Manish Ponda

The Rockefeller University

Phone: 212-327-7631

Email: mponda@rockefeller.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place