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| ID | Type | Description | Link |
|---|---|---|---|
| SQ2011SF12-20121010 | Registry Identifier | Ying-xuan Chen |
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| Name | Class |
|---|---|
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
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| 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). |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| folic acid | Drug | Patients receive oral folic acid 1mg daily for 36 months in the absence of unacceptable toxicity or any other adverse effects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to investigate the incidence of colorectal adenoma (CRA) after Folic acid, calcium and vitamin D intervention. | baseline and 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of advanced colorectal adenoma (A-CRA) after Folic acid, calcium and vitamin D intervention. | baseline and 3 years | |
| changes in serum calcium | baseline and 3 years | |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in routine blood count, urine and stool routine test, liver and kidney functions | baseline and 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing-Yuan Fang, M.D.,Ph D. | Contact | fangjingyuan_new@163.com | ||
| Ying-xuan Chen, M.D.,Ph D. | Contact | yingxuanchen71@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing-yuan Fang, MD., Ph D. | Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Recruiting | Shanghai | 200001 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| D002118 | Calcium |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| folic acid calcium vitamin D3 | Drug | 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 . |
|
| calcium | Drug | calcium 1200mg/d + vitamin D3 250 IU/d daily supplements |
|
| changes in serum FA |
| baseline and 3 years |
| the incidence of colorectal cancer (CRC) after Folic acid, calcium and vitamin D intervention. | baseline and 3 years |
| changes in clinical symptoms scores (positive immunochemical fecal occult blood test (iFOBT), diarrhea, or constipation et al) | baseline and 3 years |
| differences in Histological types of CRA OR CRC | baseline and 3 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006571 | Heterocyclic Compounds |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |