Effect of a One Time Dose of Cholecalciferol on Serum Concentration of 25-Hydroxyvitamin D and Macrophages

NCT02920502 | Completed Phase 3

• 1 other identifier: 06-13-15
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Optimal Vitamin D dosing to obtain adequate serum concentrations of 25-hydroxyvitamin D (25OHD) is controversial. The optimal dose and dosing interval is unknown, and the tendency over the last few years is to give higher, less frequent doses. Disease-specific dosing is of interest, and there may be optimal serum concentration targets based on disease process. The best evidence so far is for optimal bone health, where most experts agree that 25OHD serum concentration should be above 30 ng/ml. There is mounting evidence that Vitamin D therapy will reduce inflammatory response and macrophage activation. The optimal dosing needed to decrease the inflammatory response is unclear, although our recent mouse model has demonstrated that a onetime high dose is effective. The investigators therefore hypothesize that a one-time high dose of cholecalciferol will be effective in suppression of macrophage production of tumor necrosis factor-alpha (TNFa) and inducible nitric oxide synthase (iNOS). The purpose of this pilot study is to assess the optimum dosage for the most macrophage suppression.

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

• Primary Measure Assessing Change of Erythema and Edema

  MED testing \& Recovery from UV-induced erythema and edema before a one time dose of cholecalciferol

  24 hours, 48 hours, 72 hours, 1 week, 2 weeks

Secondary Outcomes (1)

• Secondary Measure Assessing Change of Serum Vitamin D Levels and Skin Inflammation

  Before:24 hours, 48 hours, 72 hours, 1 week, 2 weeks ; After: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month

Study Arms (4)

Arm 1: Placebo

PLACEBO COMPARATOR

Normal Healthy Volunteers without any skin pathology, will receive placebo

Other: Arm 1: Placebo

Arm 2: cholecalciferol: 50,000 IU

EXPERIMENTAL

Normal healthy Volunteers will randomized into one of three groups and receive a one time dose of cholecalciferol at 50,000 IU.

Dietary Supplement: Arm 2: cholecalciferol 50,000 IU

Arm 3: cholecalciferol: 100,000 IU

EXPERIMENTAL

Normal healthy volunteers will randomized into one of three groups and receive a one time dose of cholecalciferol at 100,000 IU.

Dietary Supplement: Arm 3: cholecalciferol 100,000 IU

Arm 4: cholecalciferol: 200,000 IU

EXPERIMENTAL

Normal Healthy volunteers will randomized into one of three groups and receive a one time dose of cholecalciferol at 200,000 IU.

Dietary Supplement: Arm 4: cholecalciferol 200,000 IU

Interventions

Arm 2: cholecalciferol 50,000 IU DIETARY_SUPPLEMENT

One time dose of cholecalciferol 50,000 IU

Arm 2: cholecalciferol: 50,000 IU

Arm 3: cholecalciferol 100,000 IU DIETARY_SUPPLEMENT

One time dose of cholecalciferol 100,000 IU

Arm 3: cholecalciferol: 100,000 IU

Arm 4: cholecalciferol 200,000 IU DIETARY_SUPPLEMENT

One time dose of cholecalciferol 200,000 IU

Arm 4: cholecalciferol: 200,000 IU

Arm 1: Placebo OTHER

One time dose of Placebo

Arm 1: Placebo

Eligibility Criteria

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

You may qualify if:

• Adults ages 18 years or older
• Fitzpatrick Skin Type I-Ill
• In good general health and able to list all current medications and medical conditions
• Capable of giving informed consent

You may not qualify if:

• Volunteers ages 18 years or younger
• Women who are pregnant, nursing, or who may become pregnant in the next 3 months
• Participants taking illegal drugs
• Chronic medical conditions
• Currently taking statins, ketoconazole, colestipol, cholestyramine, phenobarbitol, phenytoin, or mineral oil
• Currently consuming 800 IU or more of vitamin D a day
• Current or recent use of anti-inflammatory medications or any other medications that may cause photosensitivity, at the discretion of the Pl.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (3)

• Heaney RP, Armas LA, Shary JR, Bell NH, Binkley N, Hollis BW. 25-Hydroxylation of vitamin D3: relation to circulating vitamin D3 under various input conditions. Am J Clin Nutr. 2008 Jun;87(6):1738-42. doi: 10.1093/ajcn/87.6.1738.

  PMID: 18541563 BACKGROUND

• Sanders KM, Stuart AL, Williamson EJ, Simpson JA, Kotowicz MA, Young D, Nicholson GC. Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. JAMA. 2010 May 12;303(18):1815-22. doi: 10.1001/jama.2010.594.

  PMID: 20460620 BACKGROUND

• van Groningen L, Opdenoordt S, van Sorge A, Telting D, Giesen A, de Boer H. Cholecalciferol loading dose guideline for vitamin D-deficient adults. Eur J Endocrinol. 2010 Apr;162(4):805-11. doi: 10.1530/EJE-09-0932. Epub 2010 Feb 5.

  PMID: 20139241 BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kurt Lu, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 30, 2016
• Study Start: June 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 10, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)