NCT00512850已完成不适用
The Nurses' Health Study (NHS) and Health Professionals Follow-Up Study (HPFS) Folic Acid Prevention Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 672
- 主要终点
- Recurrent colorectal adenoma
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming. The use of folic acid may prevent colorectal cancer.
PURPOSE: This randomized clinical trial is studying how well folic acid works compared with a placebo in preventing colorectal polyps in patients who have had previous colorectal polyps.
详细描述
OBJECTIVES:
Primary
- Determine if folic acid supplementation lowers the adenoma recurrence rate.
Secondary
- Determine the number of adenomas per patient and the size and histology of the adenoma.
- Assess the interaction between folic acid and alcohol, methionine, and aspirin intake.
- Assess the interaction between folic acid and pretrial and midtrial folate levels.
- Assess other complementary biomarkers such as DNA methylation and blood folate level as risk factors for polyp recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Inclusion criteria:
- •Participated in the Nurses' Health Study (NHS I) or the Health Professionals Follow-Up Study (HPFS) and have had a previous confirmed diagnosis of adenomatous polyp of the colon or rectum
- •Plan on having an endoscopy within 4 years after initiation of the trial
- •Must release medical records regarding past and any future endoscopies
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •Plasma vitamin B12 concentration of ≥ 300 pg/mL or have a vitamin B12 concentration between 200 and 299 pg/mL and a methylmalonic acid (MMA) level ≤ 32 µg/L
排除标准
- •Diagnosis of cancer other than non-melanoma skin cancer, or early stage breast or prostate cancer
- •Diagnosis of homocystinemia
- •Diagnosis of pernicious anemia
- •Any gastrointestinal disorder that could lead to a vitamin B12 deficiency
- •Diagnosis of cirrhosis or pancreatitis
- •Diagnosis of epilepsy, Alzheimer's disease, Parkinsonism, and psychiatric disorders that may interfere with normal functioning
- •PRIOR CONCURRENT THERAPY:
- •Exclusion criteria:
- •No prior gastrectomy, total colectomy, or pancreatectomy
- •Other concurrent multivitamins or supplements that contain folic acid (they may take specific supplements, such as A, C, E, calcium, and iron, or antioxidant formula vitamins)
- •No concurrent methotrexate or anticonvulsant
研究组 & 干预措施
Folic acid
Other
Folic acid supplement 1g/day
干预措施: Folic acid (Dietary Supplement)
Placebo
Other
Placebo pill once per day
干预措施: Placebo (Other)
结局指标
主要结局
Recurrent colorectal adenoma
时间窗: May 1996-March 2004
次要结局
- recurrent adenoma by location, size, stage, number,(May1996-March 2004)
研究者
Edward Giovannucci
Edward Giovannucci, MD
Brigham and Women's Hospital
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