NCT02143505

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

May 21, 2014

Status Verified

May 1, 2014

Enrollment Period

2.9 years

First QC Date

May 17, 2014

Last Update Submit

May 17, 2014

Conditions

Colorectal Adenoma

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after calcium plus vitamin D intervention.

    3 years

Secondary Outcomes (1)

  • The recurrence rates of advanced colorectal adenoma (A-CRA) after calcium plus vitamin D intervention.

    3 years

Other Outcomes (6)

  • 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

    3 years

  • +3 more other outcomes

Study Arms (2)

Ca plus vit D

EXPERIMENTAL

elemental calcium 1200mg/d plus vitamin D3 250 IU/d daily supplements for 3 years

Drug: Ca plus vit D

placebo

PLACEBO COMPARATOR

identical-appearing placebo supplements for 3 years

Interventions

Ca plus vit DDRUG

elemental calcium 1200mg/d plus vitamin D3 250 IU/d daily supplements

Also known as: Caltrate
Ca plus vit D

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Institute of Digestive Disease

Shanghai, 200001, China

RECRUITING

MeSH Terms

Interventions

Calcium Carbonate

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Jing-Yuan Fang, M.D., Ph.D

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing-Yuan Fang, M.D., Ph.D

CONTACT

86-21-53882450fangjingyuan_new@163.com

Ying-Xuan Chen, M.D., Ph.D

CONTACT

86-21-63200874yingxuanchen71@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Gastroenterology

Study Record Dates

First Submitted

May 17, 2014

First Posted

May 21, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2017

Study Completion

February 1, 2019

Last Updated

May 21, 2014

Record last verified: 2014-05

Locations

CN(1)