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

NCT01447355 | Completed Phase 1

• 5 other identifiers: NCI-2011-03469CDR000071296311-0270-04UAZ10-16-03N01CN35158
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy, no Evidence of Disease; Skin Cancer

Outcome Measures

Primary Outcomes (1)

• Changes in VDR expression from baseline to post-intervention

  From baseline to post-intervention

Secondary Outcomes (5)

• Modulation in CYP24 expression in keratinocytes in photoprotected and photodamaged areas

  Up to 9 weeks

• Modulation of VDR in keratinocytes in photodamaged skin

  Up to 9 weeks

• Changes in a panel of biomarkers of skin differentiation including caspase 14, loricrin, and stratum corneum thickness in keratinocytes in photo-protected and damaged skin

  From baseline to 9 weeks

• Changes in 25-hydroxyvitamin D serum levels

  From baseline to 9 weeks

• Changes in calcium, phosphate, and PTH

  From baseline to 9 weeks

Study Arms (1)

Prevention (cholecalciferol)

EXPERIMENTAL

Participants receive cholecalciferol PO twice weekly for up to 8-9 weeks.

Drug: cholecalciferol

Interventions

cholecalciferol DRUG

Given PO

Also known as: Calciol, Vitamin D3

Prevention (cholecalciferol)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Clara Curiel-Lewandrowski

  University of Arizona Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 6, 2011
• Study Start: August 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: June 1, 2013
• Last Updated: October 8, 2014

Record last verified: 2013-09

Locations

US (1)