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| Name | Class |
|---|---|
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
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Calcium plus vitamin D may be effective in the prevention of colorectal adenoma recurrence. The aim of this study is to investigate the effect of supplementation with calcium plus vitamin D on the recurrence of colorectal adenomas.
Colorectal adenomas are well-known to be precancerous lesions that develop into colorectal cancers on the basis of the adenoma-carcinoma sequence. The effects of screening for colorectal adenomas and removing precancerous lesions on the prevention of colorectal cancer have been established. Because of the high recurrence rates of colorectal adenomas in patients who have undergone polypectomy, the potential chemopreventive agents that may reduce the risk of colorectal adenoma recurrence need to be investigated. Since laboratory and epidemiologic evidence suggests that calcium or vitamin D may help prevent colorectal adenomas, we conduct a randomized, placebo-controlled, prospective clinical trial to study the effect and safety of calcium plus vitamin D supplementation in prevention of colorectal adenomas recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ca plus vit D | Experimental | elemental calcium 1200mg/d plus vitamin D3 250 IU/d daily supplements for 3 years |
|
| placebo | Placebo Comparator | identical-appearing placebo supplements for 3 years |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ca plus vit D | Drug | elemental calcium 1200mg/d plus vitamin D3 250 IU/d daily supplements |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after calcium plus vitamin D intervention. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| The recurrence rates of advanced colorectal adenoma (A-CRA) after calcium plus vitamin D intervention. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| changes in serum calcium | baseline and 3 years | |
| changes in serum 25-(OH) Vit D level | baseline and 3 years | |
| the incidence of colorectal cancer (CRC) after calcium plus vitamin D intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing-Yuan Fang, M.D., Ph.D | Contact | 86-21-53882450 | fangjingyuan_new@163.com | |
| Ying-Xuan Chen, M.D., Ph.D | Contact | 86-21-63200874 | yingxuanchen71@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing-Yuan Fang, M.D., Ph.D | Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Institute of Digestive Disease | Recruiting | Shanghai | 200001 | China |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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| 3 years |
| changes in clinical symptoms scores (positive iFOBT, diarrhea, or constipation et al) | baseline and 3 years |
| differences in the number, location, size and histological subtype of CRA | baseline and 3 years |
| changes in routine blood count, urine and stool routine test, liver and kidney functions, etc | baseline and 3 years |
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |