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

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ClinicalTrials.gov Identifier: NCT04308850
Recruitment Status : Unknown
Verified October 2020 by Second Affiliated Hospital of Wenzhou Medical University.
Recruitment status was:  Not yet recruiting
First Posted : March 16, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Wenzhou Medical University

Study Description
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Brief Summary:

Aims:Prospectively observe the effects of Vitamin D drops supplementation on the chronic course of Crohn's disease patients, analyze whether the effect of Vitamin D drops on CD patients is affected by factors such as disease site, disease activity, treatment, etc.Exploring the relationship between Fok I gene polymorphism and the efficacy of vitamin D supplementation. 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 Fok I gene polymorphism in all participants.One group is given Vitamin D drops 400IU per day orally, and the control group do not intervene. Participants' disease activity is assessed at baseline and related indicators are determined. The disease activity is re-evaluated at 2, 6, 14, 22, 30, and 38 weeks, and the serum indexes are re-evaluated.Investigators use statistical methods to analyze whether Vitamin D drops supplementation treatment can increase the serum 25 (OH) D level of CD participants who are treated with infliximab, improve the condition of CD participants,relationship with Fok I gene polymorphism，and analyze the effects of Vitamin D drops 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: Vitamin D drops 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. Other diagnostic criterions include vitamin D deficiency (<= 20ng / ml) and treatment with infliximab. Exclusion criteria include 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 Fok I gene polymorphism using Snapshot technology.
  6. The level of serum 25 (OH) D of participants is detected.
  7. Serum C-reactive protein, erythrocyte sedimentation rate, albumin, calcium and phosphorus levels are measured.
  8. Develop a treatment plan for all participants.
  9. Participants are divided into two groups, one group is given oral vitamin D drops 400IU/ d, and the other group do not intervene.
  10. The disease activity is re-evaluated at 2, 6, 14, 22, 30, and 38 weeks, and the above serum indexes are re-evaluated.

  11. Follow-up for 38 weeks. By comparing the above indicators, observe that in the Han population:

    1. Can Vitamin D drops supplementation increase serum 25 (OH) D levels in patients with CD who are treated with infliximab?
    2. Can Vitamin D drops supplementation improve the condition of patients with CD who are treated with infliximab?
    3. Whether Fok I gene polymorphism affect the efficacy of Vitamin D drops supplementation therapy?
    4. Whether the effects of Vitamin D drops on CD patients who are treated with infliximab is affected by factors such as disease site, disease activity, treatment, etc ..
  12. Through statistical analysis, comprehensive analysis of the effectiveness and safety of Vitamin D drops supplementation in Han patients with CD who are treated with infliximab，and its relationship with Fok I gene polymorphism, providing a theoretical basis for further "precise treatment" intervention in inflammatory bowel disease.
Study Design
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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 Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D Deficiency，a Prospective Cohort Study
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Vitamin D drops
This group of patients are going to supplemented with Vitamin D drops 400IU / d orally.
 Drug: Vitamin D drops
Vitamin D-deficient CD patients are divided into two groups, one group is given orally with Vitamin D drops 400IU / d, while the other group do not interfere.
No Intervention: Control
The other group do not interfere.


Outcome Measures
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Primary Outcome Measures :
  1. Genotype frequency of vitamin D receptor single nucleotide polymorphisms in participants [ Time Frame: 9month ]
    Genotype frequency of vitamin D receptor single nucleotide polymorphisms in participants can reflect whether it is related to the severity of the disease and how much relevance.

  2. Serum 25 (OH) D level [ Time Frame: 9month ]
    Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.


Secondary Outcome Measures :
  1. Blood calcium and phosphorus level [ Time Frame: 9month ]
    Monitoring serum calcium and phosphorus levels to prevent toxic side effects.

  2. erythrocyte sedimentation rate [ Time Frame: 9month ]
    ESR can be used to reflect the degree of inflammation in the body.

  3. Concentration of C-reactive protein in participants [ Time Frame: 9month ]
    Concentration of C-reactive protein can be used to reflect the degree of inflammation in the human body.


Eligibility Criteria
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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
  • Receiving infliximab treatment
Contacts and Locations
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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): NCT04308850


Contacts
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Contact: Xia sheng long, Master 0086-15868532956 xsl1989@foxmail.com

Locations
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China, Zhejiang
SAHWenzhouMU
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Second Affiliated Hospital of Wenzhou Medical University
Investigators
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Principal Investigator: Xia sheng long, Master Second Affiliated Hospital of Wenzhou Medical University
More Information
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Responsible Party: Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04308850    
Other Study ID Numbers: SAHoWMU-CR2020-01-104
First Posted: March 16, 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Vitamin D Deficiency
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Avitaminosis
 Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents