Colorectal NeoplasmsPhase 2/3NCT02066688
Study of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer
A Phase 2/3 study testing folic acid, folic acid calcium vitamin D3 and calcium in people with Colorectal Neoplasms, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Folic acid (FA) and its derivatives (folate) which play a role in nucleotide synthesis and methylation reactions as well as calcium and vitamin D are assumed to be effective in the prevention of colorectal polyps and Colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- folic acid, folic acid calcium vitamin D3 and calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,400 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2017
- Phase
- Phase 2/3
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- individuals aged 50-80 years
- Patients had undergone complete colonoscopy with no adenoma found
- Those who voluntarily sign the consent form after being fully informed and understanding the purpose and procedures of the study, characters of the disease, effect of medications, methods of related examinations, and potential risk/benefits of the study
Who cannot join
- Patients who are hypersensitive or intolerant to the drugs
- Patients who are intolerant to another colonoscopy examination
- Pregnant women, woman during breast-feeding period, or women with expect pregnancy
- Patients with diabetes mellitus, severe heart or renal disease，or cancer history
- Patients with malignant neoplasm, or suspicious colorectal cancer
- Patients who are not able to cooperate
Show all 9Show fewer
- Individuals who are involved in designing, planning or performing this experiment
- Patients with medical conditions who are not appropriate to participate the study
- Patients who are take aspirin or cyclooxygenase 2 inhibitor （COX2）.
Trial locations and contacts
1 site in 1 country.
Jing-Yuan Fang, M.D.,Ph D. contact
Ying-xuan Chen, M.D.,Ph D. contact
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, 200001
Jing-yuan Fang, MD,Ph D., jingyuanfang2007@126.com
About this study
Official title: A Randomize Controlled Trial of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer
Folic acid (FA) and its derivatives (folate) which play a role in nucleotide synthesis and methylation reactions as well as calcium and vitamin D are assumed to be effective in the prevention of colorectal polyps and Colorectal cancer (CRC). The aim of this study is to investigate the roles of FA as well as calcium and vitamin D in the prevention of CRC.
Read the detailed description
Colorectal cancer (CRC) affects approximately one million people each year with a five-year survival rate of 62% . Considerable interest has recently been focused on the relationship between the chemoprevention of colorectal polyps/CRA and CRC. Therefore, the use of nutritional compounds which are usually less afflicted with the risk of severe side effects for colorectal adenoma (CRA) prevention and health maintenance is an emerging field.
- Conditions
- Colorectal Neoplasms
- Being tested
- folic acid, folic acid calcium vitamin D3, calcium
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
folic acidDrug
Patients receive oral folic acid 1mg daily for 36 months in the absence of unacceptable toxicity or any other adverse effects.
folic acid calcium vitamin D3Drug
Patients receive oral folic acid 1mg + calcium 1200mg +vitamin D3 250 IU daily for 36 months in the absence of unacceptable toxicity or any other adverse effects .
calciumDrug
calcium 1200mg/d + vitamin D3 250 IU/d daily supplements
| Study group | Role | What they receive |
|---|---|---|
| FA | Experimental | Patients receive oral folic acid pill 1 mg daily for 36 months in the absence of unacceptable toxicity or any other adverse effects (FA Arm). Receives: Drug: folic acid |
| FA+Ca | Experimental | Patients receive oral folic acid pill 1 mg+ calcium 1200mg +vitamin D3 250 IU daily for 36 months in the absence of unacceptable toxicity or any other adverse effects(FA+Ca arm). Receives: Drug: folic acid calcium vitamin D3 |
| Ca | Experimental | Patients receive oral calcium 1200mg +vitamin D3 250 IU daily for 36 months in the absence of unacceptable toxicity or any other adverse effects (Ca Arm). Receives: Drug: calcium |
| blank control group | Placebo comparator | Patients receive oral placebo once daily for 36 months in the absence of unacceptable toxicity or any other adverse effects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to investigate the incidence of colorectal adenoma (CRA) after Folic acid, calcium and vitamin D intervention.
Measured: baseline and 3 years
Secondary outcomes (6)
the incidence of advanced colorectal adenoma (A-CRA) after Folic acid, calcium and vitamin D intervention.
Measured: baseline and 3 years
changes in serum calcium
Measured: baseline and 3 years
changes in serum FA
Measured: baseline and 3 years
the incidence of colorectal cancer (CRC) after Folic acid, calcium and vitamin D intervention.
Measured: baseline and 3 years
changes in clinical symptoms scores (positive immunochemical fecal occult blood test (iFOBT), diarrhea, or constipation et al)
Measured: baseline and 3 years
differences in Histological types of CRA OR CRC
Measured: baseline and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Responsible party
- Principal investigator, Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jing-yuan Fang, MD., Ph D., Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066688
- Sponsor's protocol ID
- SQ2011SF12RJ
- Other IDs
- SQ2011SF12-20121010
- Status last verified
- Feb 2014
- First submitted
- 17 Feb 2014
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomize Controlled Trial of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02066688
- Acronym / sponsor ID
- SQ2011SF12RJ
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 Feb 2014 (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.
Folic acid (FA) and its derivatives (folate) which play a role in nucleotide synthesis and methylation reactions as well as calcium and vitamin D are assumed to be effective in the prevention of colorectal polyps and Colorectal cancer (CRC). The aim of this study is to investigate the roles of FA as well as calcium and vitamin D in the prevention of CRC.
Detailed description
Colorectal cancer (CRC) affects approximately one million people each year with a five-year survival rate of 62% . Considerable interest has recently been focused on the relationship between the chemoprevention of colorectal polyps/CRA and CRC. Therefore, the use of nutritional compounds which are usually less afflicted with the risk of severe side effects for colorectal adenoma (CRA) prevention and health maintenance is an emerging field.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FA | Experimental | Drug: folic acidPatients receive oral folic acid pill 1 mg daily for 36 months in the absence of unacceptable toxicity or any other adverse effects (FA Arm). |
| FA+Ca | Experimental | Drug: folic acid calcium vitamin D3Patients receive oral folic acid pill 1 mg+ calcium 1200mg +vitamin D3 250 IU daily for 36 months in the absence of unacceptable toxicity or any other adverse effects(FA+Ca arm). |
| Ca | Experimental | Drug: calciumPatients receive oral calcium 1200mg +vitamin D3 250 IU daily for 36 months in the absence of unacceptable toxicity or any other adverse effects (Ca Arm). |
| blank control group | Placebo comparator | –Patients receive oral placebo once daily for 36 months in the absence of unacceptable toxicity or any other adverse effects. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- individuals aged 50-80 years
- Patients had undergone complete colonoscopy with no adenoma found
- Those who voluntarily sign the consent form after being fully informed and understanding the purpose and procedures of the study, characters of the disease, effect of medications, methods of related examinations, and potential risk/benefits of the study
Key exclusion criteria (9 listed)
- Patients who are hypersensitive or intolerant to the drugs
- Patients who are intolerant to another colonoscopy examination
- Pregnant women, woman during breast-feeding period, or women with expect pregnancy
- Patients with diabetes mellitus, severe heart or renal disease，or cancer history
- Patients with malignant neoplasm, or suspicious colorectal cancer
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 acidPatients receive oral folic acid 1mg daily for 36 months in the absence of unacceptable toxicity or any other adverse effects. | Drug | FA |
| folic acid calcium vitamin D3Patients receive oral folic acid 1mg + calcium 1200mg +vitamin D3 250 IU daily for 36 months in the absence of unacceptable toxicity or any other adverse effects . | Drug | FA+Ca |
| calciumcalcium 1200mg/d + vitamin D3 250 IU/d daily supplements | Drug | Ca |
Primary outcome
The primary objective of this study is to investigate the incidence of colorectal adenoma (CRA) after Folic acid, calcium and vitamin D intervention.
Time frame: baseline and 3 years
6 secondary outcomes
the incidence of advanced colorectal adenoma (A-CRA) after Folic acid, calcium and vitamin D intervention.
Time frame: baseline and 3 years
changes in serum calcium
Time frame: baseline and 3 years
changes in serum FA
Time frame: baseline and 3 years
the incidence of colorectal cancer (CRC) after Folic acid, calcium and vitamin D intervention.
Time frame: baseline and 3 years
changes in clinical symptoms scores (positive immunochemical fecal occult blood test (iFOBT), diarrhea, or constipation et al)
Time frame: baseline and 3 years
differences in Histological types of CRA OR CRC
Time frame: baseline and 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2014.
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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.
Jing-Yuan Fang, M.D.,Ph D. contact
Ying-xuan Chen, M.D.,Ph D. contact
Jing-yuan Fang, MD., Ph D. principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing folic acid, folic acid calcium vitamin D3 and calcium in people with Colorectal Neoplasms, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing-Yuan Fang, M.D.,Ph D. (fangjingyuan_new@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this study is to investigate the incidence of colorectal adenoma (CRA) after Folic acid, calcium and vitamin D intervention. (time frame: baseline and 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2014.