Adenoma of Large IntestineNCT00512850
Folic Acid in Preventing Colorectal Polyps in Patients With Previous Colorectal Polyps
A study testing Folic acid in people with Adenoma of Large Intestine, run by Brigham and Women's Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Adenoma of Large Intestine
- What is being tested?
- Folic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 672 participants
- Where
- No sites listed yet
- Study dates
- May 1996to 1 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- 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
Who cannot join
- 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
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- PRIOR CONCURRENT THERAPY:
- 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
About this study
Official title: The Nurses' Health Study (NHS) and Health Professionals Follow-Up Study (HPFS) Folic Acid Prevention Trial
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.
Read the detailed description
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.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral folic acid once daily.
- Arm II: Patients receive oral placebo once daily. At least 1 year after beginning treatment, patients are sent a blood collection kit in order to measure plasma vitamin B12 levels, to measure folate to assess compliance.
- Conditions
- Adenoma of Large Intestine
- Being tested
- Folic acid, Placebo
- Keywords
- Folic acid, Adenoma of Large Intestine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic acidDietary supplement
Intervention group 1g folic acid per day
PlaceboOther
One placebo pill per day
| Study group | Role | What they receive |
|---|---|---|
| Folic acid | Other | Folic acid supplement 1g/day Receives: Dietary Supplement: Folic acid |
| Placebo | Other | Placebo pill once per day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent colorectal adenoma
Measured: May 1996-March 2004
Secondary outcomes (1)
recurrent adenoma by location, size, stage, number,
Measured: May1996-March 2004
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startMay 1996
- Primary completionMar 2004
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adenoma of Large IntestineStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 672 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Dana-Farber/Brigham and Women's Cancer Center
- Responsible party
- Principal investigator, Edward Giovannucci, Brigham and Women's Hospital
- Investigators
- Edward L. Giovannucci, MD, ScD, Principal investigator, Dana-Farber/Brigham and Women's Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512850
- Sponsor's protocol ID
- BWH-1999-P-001674/10
- Other IDs
- CDR0000559650, BWH-94-06819, R01CA067883
- Status last verified
- Mar 2017
- First submitted
- 6 Aug 2007
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wu K, Platz EA, Willett WC, Fuchs CS, Selhub J, Rosner BA, Hunter DJ, Giovannucci E. A randomized trial on folic acid supplementation and risk of recurrent colorectal adenoma. Am J Clin Nutr. 2009 Dec;90(6):1623-31. doi: 10.3945/ajcn.2009.28319. Epub 2009 Oct 28.
PubMed 19864409Figueiredo JC, Mott LA, Giovannucci E, Wu K, Cole B, Grainge MJ, Logan RF, Baron JA. Folic acid and prevention of colorectal adenomas: a combined analysis of randomized clinical trials. Int J Cancer. 2011 Jul 1;129(1):192-203. doi: 10.1002/ijc.25872. Epub 2011 Apr 1.
PubMed 21170989
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nurses' Health Study (NHS) and Health Professionals Follow-Up Study (HPFS) Folic Acid Prevention Trial
- ClinicalTrials.gov ID
- NCT00512850
- Acronym / sponsor ID
- BWH-1999-P-001674/10
- Conditions
- Adenoma of Large Intestine
- Keywords
- Folic acid, Adenoma of Large Intestine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 672 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Dana-Farber/Brigham and Women's Cancer Center
- Study start
- May 1996
- Primary completion
- Mar 2004 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 8 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral folic acid once daily.
- Arm II: Patients receive oral placebo once daily. At least 1 year after beginning treatment, patients are sent a blood collection kit in order to measure plasma vitamin B12 levels, to measure folate to assess compliance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Folic acid | Other | Dietary Supplement: Folic acidFolic acid supplement 1g/day |
| Placebo | Other | Other: PlaceboPlacebo pill once per day |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic acidIntervention group 1g folic acid per day | Dietary supplement | Folic acid |
| PlaceboOne placebo pill per day | Other | Placebo |
Primary outcome
Recurrent colorectal adenoma
Time frame: May 1996-March 2004
1 secondary outcome
recurrent adenoma by location, size, stage, number,
Time frame: May1996-March 2004
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Results publication: PubMed 19864409Wu K, Platz EA, Willett WC, Fuchs CS, Selhub J, Rosner BA, Hunter DJ, Giovannucci E. A randomized trial on folic acid supplementation and risk of recurrent colorectal adenoma. Am J Clin Nutr. 2009 Dec;90(6):1623-31. doi: 10.3945/ajcn.2009.28319. Epub 2009 Oct 28.
- Results publication: PubMed 21170989Figueiredo JC, Mott LA, Giovannucci E, Wu K, Cole B, Grainge MJ, Logan RF, Baron JA. Folic acid and prevention of colorectal adenomas: a combined analysis of randomized clinical trials. Int J Cancer. 2011 Jul 1;129(1):192-203. doi: 10.1002/ijc.25872. Epub 2011 Apr 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward L. Giovannucci, MD, ScD principal investigator
Dana-Farber/Brigham and Women's Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Folic acid in people with Adenoma of Large Intestine, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent colorectal adenoma (time frame: May 1996-March 2004). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00512850, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.