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Phase 1 Completed N=328 Randomized Quadruple-blind Prevention

Vitamin D for Chemoprevention

Cancer · Prostate Cancer · Hypertension
Source: ClinicalTrials.gov NCT00585637 ↗
Enrolled (actual)
328
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcomePrimary: Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months. — 15.1; 16.2; 13.9; 15.7 ng/mL

Summary

This study will help us know the effects of Vitamin D pills in Blacks. The results of this study may be the first step in creating ways to prevent the risks of colon and prostate cancer. It will also help us develop ways to reduce colon cancer and prostate cancer among Blacks. This study will find out if Vitamin D pills can increase Vitamin D to healthy levels in our bodies.

Outcome Measures

OutcomeResultp-value
PRIMARY
Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months.		 15.1; 16.2; 13.9; 15.7; 13.7; 29.7 —
SECONDARY
Change in IL-6 From 0 to 3 Months.		 -0.03; -0.07; 0.01; 0.08 —
SECONDARY
Change in IL-10 From 0 to 3 Months.		 0; -0.01; -0.02; 0.00 —
SECONDARY
Change in sTNF-R2 From 0 to 3 Months.		 -0.89; -9.88; 59.16; 13.29 —
SECONDARY
Change in CRP From 0 to 3 Months.		 -0.05; 0.07; 0.02; 0.03 —

Eligibility Criteria

Inclusion Criteria

  • Between the ages of 30 and 80 years
  • Comfortable communicating in English
  • Currently has a primary care physician
  • Willing to discontinue vitamin D or calcium supplements
  • Willing to have all protocol specific tests run

Exclusion Criteria

  • Plans on taking a vacation or travel to a sunny region within 3 months of vitamin supplementation period except for a short period (i.e. 1 weekend)
  • Pregnant or breast feeding or planning on becoming pregnant in the following year
  • Pre-existing calcium (including hypercalcemia), parathyroid conditions (including hyperparathyroidism), sarcoidosis
  • No concurrent active malignancies (other than non-melanoma skin cancer) or previous diagnosis of prostate cancer
  • Cognitively impaired
  • Active thyroid disease (e.g. Graves, Hashimoto's or thyroiditis)
  • History of nephrolithiasis, chronic liver disease, chronic renal disease, or renal dialysis
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00585637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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