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

Sponsor

Second Affiliated Hospital of Wenzhou Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04308850

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

The research can be started only after approval by the Medical Ethics Committee of the Second Affiliated Hospital of Wenzhou Medical University.
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.
Assess disease activity of CD participants based on the "Simplified Crohn's disease Activity Score".
General information about participants with CD is collected.
Detection of Fok I gene polymorphism using Snapshot technology.
The level of serum 25 (OH) D of participants is detected.
Serum C-reactive protein, erythrocyte sedimentation rate, albumin, calcium and phosphorus levels are measured.
Develop a treatment plan for all participants.
Participants are divided into two groups, one group is given oral vitamin D drops 400IU/ d, and the other group do not intervene.
The disease activity is re-evaluated at 2, 6, 14, 22, 30, and 38 weeks, and the above serum indexes are re-evaluated.
Follow-up for 38 weeks. By comparing the above indicators, observe that in the Han population:
Can Vitamin D drops supplementation increase serum 25 (OH) D levels in patients with CD who are treated with infliximab?
Can Vitamin D drops supplementation improve the condition of patients with CD who are treated with infliximab?
Whether Fok I gene polymorphism affect the efficacy of Vitamin D drops supplementation therapy?
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 ..
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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Apr 1, 2021

Arms and Interventions

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.

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

Primary Outcome Measures

Genotype frequency of vitamin D receptor single nucleotide polymorphisms in participants [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.
Serum 25 (OH) D level [9month]
Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.

Secondary Outcome Measures

Blood calcium and phosphorus level [9month]
Monitoring serum calcium and phosphorus levels to prevent toxic side effects.
erythrocyte sedimentation rate [9month]
ESR can be used to reflect the degree of inflammation in the body.
Concentration of C-reactive protein in participants [9month]
Concentration of C-reactive protein can be used to reflect the degree of inflammation in the human body.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	SAHWenzhouMU	Wenzhou	Zhejiang	China	325000

Sponsors and Collaborators

Second Affiliated Hospital of Wenzhou Medical University

Investigators

Principal Investigator: Xia sheng long, Master, Second Affiliated Hospital of Wenzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital of Wenzhou Medical University

ClinicalTrials.gov Identifier:

NCT04308850

Other Study ID Numbers:

SAHoWMU-CR2020-01-104

First Posted:

Mar 16, 2020

Last Update Posted:

Oct 14, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Crohn Disease

Vitamin D Deficiency

Vitamin D

Study Results

No Results Posted as of Oct 14, 2020