Vitamin D in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Study of Serum 25(OH) D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00524680
• Other study ID #: CDR0000562742
• Secondary ID: I 95406
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2007
• Last updated: September 30, 2015
• Start date: June 2007
• Est. completion date: March 2013

Study information

• Verified date: September 2015
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Vitamin D may be effective in treating patients with prostate cancer.

PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D works in treating patients with prostate cancer.

Description:

OBJECTIVES:

Primary

• To examine the pattern of response of serum 25(OH) D3 levels following cholecalciferol (vitamin D3) supplementation at four different oral doses in patients with prostate cancer.

Secondary

• To examine the pattern of response of parathormone (PTH) following vitamin D3 supplementation in these patients.

• To assess the toxicity of vitamin D3 supplementation in men with prostate cancer.

Tertiary

• To track occurrence of infections, deep vein thrombosis, vascular events, and falls in these patients.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

• Arm I: Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.

• Arm II: Patients receive 6,000 IU of vitamin D3 once daily.

• Arm III: Patients receive 8,000 IU of vitamin D3 once daily.

• Arm IV: Patients receive 10,000 IU of vitamin D3 once daily. Treatment in all arms continues for 6 months in the absence of disease progression or unacceptable toxicity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: March 2013
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• 25(OH) D3 level < 80 ng/mL

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status 0-2

• Creatinine = 2.0 mg/dL

• Corrected serum calcium = 10.5 mg/dL

Exclusion criteria:

• History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)

• Hypersensitivity to cholecalciferol or one of its components

PRIOR CONCURRENT THERAPY:

• No other concurrent vitamin D supplementation

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• cholecalciferol
Given orally

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern of Response of Serum 25(OH) D3 Levels	Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.	Baseline, at 1, 3, 6 months	No
Secondary	Pattern of Response of Parathormone	Change from Baseline in PTH Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.	Baseline, at 1, 3, 6 months	No
Secondary	Toxicity	Number of treated patients that had serious adverse events.	Baseline, at 1, 3 and 6 months	Yes
Secondary	Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls	Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls	Baseline, at 1, 3 ,6 months	No