Trial Outcomes & Findings for Pilot Trial to Evaluate the Effect of Vitamin D on Melanocyte Biomarkers (NCT NCT01477463)

Results Overview

Normal cells have a complex series of molecular signals that allow communication between cells and to the cell nucleus. These signals work together to control one or more cell functions, such as cell division or cell death. Abnormal signaling activity caused by changes in gene expression can lead to cancer. An understanding of abnormal signaling, both in the tumor and in normal tissues, may lead to new therapies in cancer patients. We wish to identify changes in molecular signaling that occur in the development of melanoma that might be suppressed in benign nevi (moles) in response to vitamin D supplementation.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

2 years

Results posted on

2016-12-23

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A: Vitamin D 4,000 IU oral vitamin D3 Vitamin D3: 4,000 IU oral vitamin D3	Arm B: Placebo Placebo - patients may cross over to vitamin D3 treatment after placebo treatment
Overall Study STARTED	18	6
Overall Study COMPLETED	18	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Trial to Evaluate the Effect of Vitamin D on Melanocyte Biomarkers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Vitamin D n=18 Participants 4,000 IU oral vitamin D3 Vitamin D3: 4,000 IU oral vitamin D3	Arm B: Placebo n=6 Participants Placebo - subjects may cross over to vitamin D treatment after placebo treatment is complete	Total n=24 Participants Total of all reporting groups
Age, Continuous	56.2 years STANDARD_DEVIATION 12.6 • n=5 Participants	55.8 years STANDARD_DEVIATION 5.7 • n=7 Participants	56.1 years STANDARD_DEVIATION 10.6 • n=5 Participants
Gender Female	18 Participants n=5 Participants	6 Participants n=7 Participants	24 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	6 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: All subjects treated with vitamin D3.

Normal cells have a complex series of molecular signals that allow communication between cells and to the cell nucleus. These signals work together to control one or more cell functions, such as cell division or cell death. Abnormal signaling activity caused by changes in gene expression can lead to cancer. An understanding of abnormal signaling, both in the tumor and in normal tissues, may lead to new therapies in cancer patients. We wish to identify changes in molecular signaling that occur in the development of melanoma that might be suppressed in benign nevi (moles) in response to vitamin D supplementation.

Outcome measures

Outcome measures
Measure	All Patients Treated With Vitamin D3 n=18 Participants 4,000 IU oral vitamin D3 Vitamin D3: 4,000 IU oral vitamin D3	Arm B: Placebo Placebo (inactive capsule)
Number of Genes That Showed Changes in Expression After Vitamin D Treatment	270 number of genes	—

PRIMARY outcome

Timeframe: 2 years

We utilized a prior gene expression study that compared malignant melanoma cells to benign nevi (moles) and identified over 2300 genes that were differentially regulated in melanoma compared to benign nevi. There were approximately 270 genes in our data set that showed changes in expression after vitamin D treatment. We wish to identify overlap between these two groups.

Outcome measures

Outcome measures
Measure	All Patients Treated With Vitamin D3 n=18 Participants 4,000 IU oral vitamin D3 Vitamin D3: 4,000 IU oral vitamin D3	Arm B: Placebo Placebo (inactive capsule)
Number of Genes Differentialy Regulated in Melanoma That Showed Changes in Expression After Vitamin D Treatment	47 number of genes	—

SECONDARY outcome

Timeframe: 2 years

serum 25(OH)D for

Outcome measures

Outcome measures
Measure	All Patients Treated With Vitamin D3 n=18 Participants 4,000 IU oral vitamin D3 Vitamin D3: 4,000 IU oral vitamin D3	Arm B: Placebo n=6 Participants Placebo (inactive capsule)
Vitamin D Toxicity	47.11 ng/ml Standard Deviation 14.5	29.83 ng/ml Standard Deviation 4.02

SECONDARY outcome

Timeframe: 2 years

Calcium levels

Outcome measures

Outcome measures
Measure	All Patients Treated With Vitamin D3 n=18 Participants 4,000 IU oral vitamin D3 Vitamin D3: 4,000 IU oral vitamin D3	Arm B: Placebo n=6 Participants Placebo (inactive capsule)
Incidence of Hypercalcemia for Vitamin D Toxicity	0 participants	0 participants

Adverse Events

Arm A: Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B: Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jean Y Tang MD PhD, assistant professor

Stanford University School of Medicine

Phone: 650-721-7149

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place