Vitamin D Levels in the Skin of Healthy Subjects After Oral Supplementation

Completed · Phase 1

Conditions studied: Healthy, no Evidence of Disease, Skin Cancer

In brief

This pilot phase I trial studies vitamin D levels in the skin of healthy subjects after oral supplementation. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of cholecalciferol, a vitamin D, may keep skin cancer from forming.

Key facts

Study ID

NCT01447355

Run by

National Cancer Institute (NCI)

People needed

25

Starts

2012-08-01

Expected to finish

2013-06-01

Last updated by the study team

2014-10-08

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Documented insufficient serum levels of 25-hydroxyvitamin D =< 30.0 ng/mL
• At least moderate sun-damaged skin on the mid-upper right dorsal forearm
• Karnofsky performance status of at least 80%
• Leukocytes âÃÂ¥ 3,000/ÃüL
• Absolute neutrophil count âÃÂ¥ 1,500/ÃüL
• Platelets âÃÂ¥ 100,000/ÃüL
• Total bilirubin âä 2.0 mg/dL
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< institutional upper limit of normal (ULN)
• Creatinine âä 1.4 mg/dL
• Serum calcium 8.4-10.6 mg/dL
• Parathyroid hormone (PTH): male 8.3-10.4 mg/dL; female 8.4-10.6 mg/dL
• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence; surgical sterilization; or at least one year post-menopausal) prior to study entry and for the duration of study participation
• Skin phototype II or III as defined according to their skin response to sunlight:
• Skin phototype II will always burn, and tan minimally after 45-60 min of unprotected exposure to the summer sun between 12-1pm
• Skin phototype III will sometimes burn, and almost always tan after 45-60 min of unprotected exposure to the summer sun between 12-1pm
• Ability to understand and willingness to sign written informed consent
• Participants may not have acute or chronic hypervitaminosis D or hypercalcemia
• No history of increased arterial calcification or atherosclerosis, sarcoidosis, histoplasmosis, hyperparathyroidism, lymphoma, or kidney disease
• No current use of digoxin (Lanoxin, digitalis), cholestyramine (Prevalite, Questran), colestipol (Cholestid), oral steroids (prednisone and others), and antacids that contain magnesium
• Participants may not be receiving any other investigational agents; if they have completed a clinical-intervention trial recently, there must be a 30-day period between completing the previous study and entering this study
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cholecalciferol, lidocaine, or xylocaine
• No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant and breastfeeding women are excluded from this study
• No invasive cancer or cancer treatment within the past five years, except non-melanoma skin cancer
• No immunosuppression by virtue of medication or disease; this includes acquired immune deficiency syndrome (AIDS) patients, subjects taking oral prednisone, and subjects on immunosuppressants/immunomodulators (cyclosporine, chemotherapeutic agents, or biologic therapy), as determined by the examining investigator/co-investigator

Where it is running

• University of Arizona Health Sciences Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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