- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01150877
High Dose Vitamin D Study
Study of High-dose Vitamin D Supplementation in Stage-4 Colorectal Cancer Patients
The purpose of this study is to investigate the therapeutic effect and the safety of high-dose vitamin D supplementation in metastatic colorectal cancer patients. We propose to supplement metastatic (stage 4) colorectal cancer patients with oral doses of vitamin D to raise serum 25-hydroxy-vitamin D [25(OH)D] levels to the high normal range of 200-250 nmol/L. The primary objective of this study is to evaluate the metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer. The secondary objective is to evaluate patient survival with regards to high-dose vitamin D supplementation.
Hypothesis:
Whereas low doses of vitamin D reportedly play a significant role in prevention of colorectal cancers, do much larger (pharmacological) doses of vitamin D have a significant therapeutic effect against the same kind of cancer?
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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British Columbia
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Vancouver, British Columbia, 캐나다, V6H 4A6
- InspireHealth
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria (We will recruit stage 4 (metastatic) colorectal cancer patients who are clients at InspireHealth):
- Age > 18
- Histologically confirmed colon or rectal cancer
- Known metastatic disease (stage-4) confirmed histologically or radiologically
- Life expectancy of >8 months
- May receive anti-neoplastic therapy at the discretion of their physician
- Stable metastatic disease defined as no change in systemic for the month before and the month after commencing study
- Signed informed consent
Exclusion Criteria(Stage 4 colorectal cancer patients):
- Pregnant / lactating women
- Known hypersensitivity to vitamin D
- Pre-existing renal stone disease based on history
- Pre-existing hypercalcemia
- Severe renal or hepatic dysfunction (≥ 2x of the upper normal range)
- granulomatous disease (TB and sarcoid)
- unable to give informed consent in English (translations of study documents in languages other than English will not be provided)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 간섭 없음
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실험적: Experimental Dietary Supplement (e.g., vitamins, minerals)
Experimental arm is supplemented with high-dose of vitamin D.
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We propose to study high-dose, oral vitamin D supplementation, raising serum 25-hydroxy-vitamin D (25(OH)D) concentrations to 200 -250 nmol/L, in metastatic colorectal cancer patients with safety, tolerability and survival as the main outcome measurements.
The dose is not pre-set and will depend on the individual subjects' serum 25(OH)D concentration.
Subjects will be supplemented for 16 months with a daily oral dose, followed by a 12 months follow-up period.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer.
기간: After 16 months of intervention
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After 16 months of intervention
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The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer.
기간: After 12 months of follow-up
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After 12 months of follow-up
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2차 결과 측정
결과 측정 |
기간 |
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Patient survival with regards to high-dose vitamin D supplementation.
기간: After 16 months of intervention
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After 16 months of intervention
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Patient survival with regards to high-dose vitamin D supplementation.
기간: After 12 months of follow-up
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After 12 months of follow-up
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hal Gunn, MD, University of British Columbia
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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