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Study of Calcium Plus Vitamin D Supplementation in Prevention of Colorectal Adenomas Recurrence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02143505
Recruitment Status : Unknown
Verified May 2014 by Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : May 21, 2014
Last Update Posted : May 21, 2014
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Adenoma Drug: Ca plus vit D Phase 2 Phase 3

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Calcium Plus Vitamin D Supplementation in Prevention of Colorectal Adenomas Recurrence:a Prospective, Randomized, Placebo-controlled, Multicenter Clinical Trial
Study Start Date : March 2014
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Vitamin D

Arm Intervention/treatment
Experimental: Ca plus vit D
elemental calcium 1200mg/d plus vitamin D3 250 IU/d daily supplements for 3 years
Drug: Ca plus vit D
elemental calcium 1200mg/d plus vitamin D3 250 IU/d daily supplements
Other Name: Caltrate

Placebo Comparator: placebo
identical-appearing placebo supplements for 3 years



Primary Outcome Measures :
  1. The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after calcium plus vitamin D intervention. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. The recurrence rates of advanced colorectal adenoma (A-CRA) after calcium plus vitamin D intervention. [ Time Frame: 3 years ]

Other Outcome Measures:
  1. changes in serum calcium [ Time Frame: baseline and 3 years ]
  2. changes in serum 25-(OH) Vit D level [ Time Frame: baseline and 3 years ]
  3. the incidence of colorectal cancer (CRC) after calcium plus vitamin D intervention [ Time Frame: 3 years ]
  4. changes in clinical symptoms scores (positive iFOBT, diarrhea, or constipation et al) [ Time Frame: baseline and 3 years ]
  5. differences in the number, location, size and histological subtype of CRA [ Time Frame: baseline and 3 years ]
  6. changes in routine blood count, urine and stool routine test, liver and kidney functions, etc [ Time Frame: baseline and 3 years ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals aged 18-65years
  • Individuals who had at least one histologically confirmed colorectal adenoma removed within three months before recruitment
  • Individuals without a history of familial polyposis
  • 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

Exclusion Criteria:

  • Patients who are hypersensitive or intolerant to the drugs
  • Patients who are intolerant to another colonoscopy examination
  • Patients with hypercalcemia or urolithiasis
  • Pregnant women, women during breast-feeding period, or women with expect pregnancy
  • Patients with diabetes mellitus, severe heart or renal disease, or cancer history
  • Patients with a history of subtotal gastrectomy or partial bowel resection
  • Patients who are not able to cooperate
  • Individual who are involved in designing, planning or performing this clinical trial
  • Patients with medical conditions who are not appropriate to participate the study
  • Patients who are taking aspirin, NSAIDs or COX2 inhibitors
  • Patients who are taking folic acid or Butyrate.
  • Patients with IBD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143505


Contacts
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Contact: Jing-Yuan Fang, M.D., Ph.D 86-21-53882450 fangjingyuan_new@163.com
Contact: Ying-Xuan Chen, M.D., Ph.D 86-21-63200874 yingxuanchen71@126.com

Locations
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China
Shanghai Institute of Digestive Disease Recruiting
Shanghai, China, 200001
Principal Investigator: jing-yuan Fang, MD. Ph D.         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Ministry of Science and Technology of the People´s Republic of China
Investigators
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Principal Investigator: Jing-Yuan Fang, M.D., Ph.D Shanghai Jiao Tong University School of Medicine

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Responsible Party: Jing-yuan Fang, MD, Ph. D, Director of Department of Gastroenterology, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02143505    
Other Study ID Numbers: 2014BAI09B05
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Adenoma
Recurrence
Disease Attributes
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Vitamin D
Ergocalciferols
Calcium, Dietary
Vitamins
Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents