We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency

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: NCT04276636
Recruitment Status : Unknown
Verified October 2020 by Second Affiliated Hospital of Wenzhou Medical University.
Recruitment status was:  Not yet recruiting
First Posted : February 19, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Wenzhou Medical University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Aims:Prospectively observe the effects of Caltrate supplementation on the chronic course of Crohn's disease patients, analyze whether the effect of Caltrate on CD patients is affected by factors such as disease site, disease activity, treatment, etc.Provide a certain theoretical basis for "precision treatment" for CD patients in the future.

Design：It is a prospective cohort study. Investigators include a total of 60 participants with CD according to the inclusion and exclusion criteria, and divide them into two groups to assess their initial disease activity and detect related indicators. At the same time，Investigators detect the Vitamin D Gene gene polymorphisms in all participants.One group is given Caltrate 0.6g per day orally, and the control group do not intervene. After 12 months, re-evaluate the disease activity and retest the relevant indicators, and use statistical methods to analyze whether Caltrate supplementation treatment can increase the serum 25 (OH) D level of CD participants, improve the condition of CD participants,relationship with Vitamin D Gene Polymorphism，and analyze the effect of Caltrate on participants with CD is affected by factors such as disease site, disease activity, and treatment.


Condition or disease Intervention/treatment Phase
Crohn's Disease Vitamin D Deficiency Vitamin D Supplement Drug: Caltrate Pill Early Phase 1

Detailed Description:
  1. The research can be started only after approval by the Medical Ethics Committee of the Second Affiliated Hospital of Wenzhou Medical University.
  2. According to the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease" formulated by the Beijing Conference in 2018 as a standard, patients with clear diagnosis of CD are collected. Exclusion criteria included pregnancy, breastfeeding, liver and kidney dysfunction, concurrent autoimmune diseases, and use of antiepileptic drugs or drugs metabolized by liver cytochrome P450 enzymes.
  3. Assess disease activity of CD participants based on the "Simplified Crohn's disease Activity Score".
  4. General information about participants with CD is collected.
  5. Detection of VDR gene polymorphisms using Snapshot technology.
  6. Serum C-reactive protein, erythrocyte sedimentation rate, white blood cells, albumin, creatinine, alanine aminotransferase, calcium and phosphorus levels are measured.
  7. The level of serum 25 (OH) D of participants is detected.
  8. Develop a treatment plan for participants.
  9. Participants are divided into two groups, one group is given oral Caltrate 0.6g / d, and the other group did not intervene.
  10. The above serum indicators are re-measured in the 12th month, and the condition of CD participants is also evaluated.

  11. Follow-up for 12 months. By comparing the above indicators, observe that in the Han population:

    1. Can Caltrate supplementation increase serum 25 (OH) D levels in patients with CD?
    2. Can Caltrate supplementation improve the condition of patients with CD?
    3. whether vitamin D gene polymorphisms affect the efficacy of Caltrate supplementation therapy?
    4. Analyze whether the effect of Caltrate on CD patients is affected by factors such as disease site, disease activity, treatment, etc ..
  12. Through statistical analysis, comprehensive analysis of the effectiveness and safety of Caltrate supplementation in Han patients with CD, and its relationship with vitamin D gene polymorphisms, providing a theoretical basis for further "precise treatment" intervention in inflammatory bowel disease.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency，a Prospective Cohort Study
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Caltrate
This group of patients are going to supplemented with Caltrate 0.6 g / d orally.
 Drug: Caltrate Pill
Vitamin D-deficient CD patients are divided into two groups, one group is given orally with Caltrate Pill 0.6 g / d, while the other group do not interfere.
No Intervention: Control
The other group do not interfere.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Serum 25 (OH) D level [ Time Frame: 1year ]
    Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.


Secondary Outcome Measures :
  1. White blood cell count [ Time Frame: 1year ]
    White blood cell count can be used to reflect the degree of inflammation in the body

  2. erythrocyte sedimentation rate [ Time Frame: 1year ]
    ESR can be used to reflect the degree of inflammation in the body.

  3. C-reactive protein. [ Time Frame: 1year ]
    C-reactive protein can be used to reflect the degree of inflammation in the human body


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clearly diagnosed patients with CD
  • Vitamin D deficiency (<= 20ng / ml)

Exclusion Criteria:

  • Pregnancy, lactation
  • Liver and kidney insufficiency
  • Co-morbid with other autoimmune diseases
  • Use antiepileptic drugs or drugs metabolized by liver cytochrome P450 enzymes
  • Vitamin D level is normal or high
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04276636


Contacts
Layout table for location contacts
Contact: Xia sheng long, Master 0086-15868532956 xsl1989@foxmail.com

Locations
Layout table for location information
China, Zhejiang
SAHWenzhouMU
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Second Affiliated Hospital of Wenzhou Medical University
Investigators
Layout table for investigator information
Principal Investigator: Xia Xia long, Master Second Affiliated Hospital of Wenzhou Medical University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04276636    
Other Study ID Numbers: SAHoWMU-CR2020-01-102
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data sets will be made available on relevant requests and in accordance with journal guidelines when publishing results from this study.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Vitamin D Deficiency
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Avitaminosis
 Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcium Carbonate
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents