Healthy, no Evidence of DiseasePhase 1NCT01447355
Vitamin D Levels in the Skin of Healthy Subjects After Oral Supplementation
A Phase 1 study testing cholecalciferol in people with Healthy, no Evidence of Disease and Skin Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, no Evidence of Disease, Skin Cancer
- What is being tested?
- cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 32Show fewer
- 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
- Unwilling or unable to refrain from taking herbal medicines or above-standard vitamin or mineral during the study
- A standard daily multivitamin/mineral supplement is acceptable if it contains ̉̊ 600 IU of vitamin D, or ̉̊ the recommended dietary allowance (RDA) of calcium, and the subject has been taking a stable dose for at least 30 days
- Potential subjects who are taking above-standard doses of supplements may be re-considered for participation after a 30-day wash-out period
- No participants who have used tanning beds or other methods to promote sun-tanning within 6 months of study entry; such practices may not be undertaken during participation in the study
- Participants unwilling to minimize their exposure to sunlight by applying sunscreen/sunblock or by wearing clothing to shield their skin, during outdoor activities, while they are enrolled in the study
- Individuals receiving concurrent topical therapy with retinoids, steroids, 5-fluorouracil, Levulan, Vaniqa (eflornithine), Solaraze, or Imiquimod (AldaraÃÃî) within 30 days prior to study enrollment will be excluded; subjects may be reconsidered for eligibility 30 days after the last treatment
- Individuals who have had treatment for basal cell carcinoma or squamous cell carcinoma on the skin of the right forearm within six months prior to evaluation for the study will not be eligible; these subjects will be encouraged to return for re-evaluation once the six-month period is over
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Health Sciences Center
Tucson, Arizona, 85724
About this study
Official title: Pilot Study on the Bioactivity of Vitamin D in the Skin After Oral Supplementation
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if high-dose oral cholecalciferol supplementation increases vitamin D receptor (VDR) expression in keratinocytes from photoprotected areas in healthy subjects with documented insufficient serum levels of 25-hydroxyvitamin D (defined as =< 30.0 ng/mL).
SECONDARY OBJECTIVES:
- To assess the modulation in CYP24 expression in keratinocytes (from photoprotected and photodamaged skin samples).
II. To assess the modulation in VDR expression in keratinocytes (from photodamaged skin samples).
III. To assess the mechanistic information concerning the action of cholecalciferol supplementation in the state of keratinocytic differentiation by assessing caspase 14, loricrin, and assessment of stratum corneum thickness.
IV. To assess the safety and tolerability of high-dose cholecalciferol supplementation in this patient cohort, including the evaluation of calcium, phosphate, and parathyroid hormone (PTH).
- To assess the 25-hydroxyvitamin D levels after intervention supplementation.
TERTIARY OBJECTIVES:
- To assess the corresponding VDR and CYP24 expression in benign melanocytic nevi. (Exploratory)
OUTLINE:
Participants receive cholecalciferol orally (PO) twice weekly for up to 8-9 weeks.
After completion of study treatment, participants are followed up for 10-14 days.
- Conditions
- Healthy, no Evidence of Disease, Skin Cancer
- Being tested
- cholecalciferol
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferolDrug
Also called Calciol, Vitamin D3
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Prevention (cholecalciferol) | Experimental | Participants receive cholecalciferol PO twice weekly for up to 8-9 weeks. Receives: Drug: cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in VDR expression from baseline to post-intervention
Measured: From baseline to post-intervention
Secondary outcomes (5)
Modulation in CYP24 expression in keratinocytes in photoprotected and photodamaged areas
Measured: Up to 9 weeks
Modulation of VDR in keratinocytes in photodamaged skin
Measured: 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
Measured: From baseline to 9 weeks
Changes in 25-hydroxyvitamin D serum levels
Measured: From baseline to 9 weeks
Changes in calcium, phosphate, and PTH
Measured: From baseline to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startAug 2012
- Primary completionOct 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, no Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Clara Curiel-Lewandrowski, Principal investigator, University of Arizona Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447355
- Sponsor's protocol ID
- NCI-2011-03469
- Other IDs
- NCI-2011-03469, CDR0000712963, 11-0270-04, UAZ10-16-03, N01CN35158
- Status last verified
- Sep 2013
- First submitted
- 4 Oct 2011
- Last updated
- 8 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Bioactivity of Vitamin D in the Skin After Oral Supplementation
- ClinicalTrials.gov ID
- NCT01447355
- Acronym / sponsor ID
- NCI-2011-03469
- Conditions
- Healthy, no Evidence of Disease, Skin Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Aug 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To determine if high-dose oral cholecalciferol supplementation increases vitamin D receptor (VDR) expression in keratinocytes from photoprotected areas in healthy subjects with documented insufficient serum levels of 25-hydroxyvitamin D (defined as =< 30.0 ng/mL).
SECONDARY OBJECTIVES:
- To assess the modulation in CYP24 expression in keratinocytes (from photoprotected and photodamaged skin samples).
II. To assess the modulation in VDR expression in keratinocytes (from photodamaged skin samples).
III. To assess the mechanistic information concerning the action of cholecalciferol supplementation in the state of keratinocytic differentiation by assessing caspase 14, loricrin, and assessment of stratum corneum thickness.
IV. To assess the safety and tolerability of high-dose cholecalciferol supplementation in this patient cohort, including the evaluation of calcium, phosphate, and parathyroid hormone (PTH).
- To assess the 25-hydroxyvitamin D levels after intervention supplementation.
TERTIARY OBJECTIVES:
- To assess the corresponding VDR and CYP24 expression in benign melanocytic nevi. (Exploratory)
OUTLINE:
Participants receive cholecalciferol orally (PO) twice weekly for up to 8-9 weeks.
After completion of study treatment, participants are followed up for 10-14 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (cholecalciferol) | Experimental | Drug: cholecalciferolParticipants receive cholecalciferol PO twice weekly for up to 8-9 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholecalciferolAlso: Calciol, Vitamin D3Given PO | Drug | Prevention (cholecalciferol) |
Primary outcome
Changes in VDR expression from baseline to post-intervention
Time frame: From baseline to post-intervention
5 secondary outcomes
Modulation in CYP24 expression in keratinocytes in photoprotected and photodamaged areas
Time frame: Up to 9 weeks
Modulation of VDR in keratinocytes in photodamaged skin
Time frame: 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
Time frame: From baseline to 9 weeks
Changes in 25-hydroxyvitamin D serum levels
Time frame: From baseline to 9 weeks
Changes in calcium, phosphate, and PTH
Time frame: From baseline to 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clara Curiel-Lewandrowski principal investigator
University of Arizona Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cholecalciferol in people with Healthy, no Evidence of Disease and Skin Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in VDR expression from baseline to post-intervention (time frame: From baseline to post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2014.