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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02704624 |
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Date of registration:
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24/02/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Supplementation of Vitamin D in Patients With Crohn's Disease
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Scientific title:
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The Impact of Serum Vitamin D and Calcium Levels on the Body Composition, Bone Mineral Density, Muscle Strength, Exercise Tolerance, Fatigue and Inflammatory Activity in Patients With Crohn's Disease: a Randomized Controlled Trial |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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110 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://clinicaltrials.gov/show/NCT02704624 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Júlio MF Chebli, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of Juiz de Fora |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of Crohn's Disease (moderate to severe)
- Remission of Crohn's activity
- Reduced blood levels of vitamin D
Exclusion Criteria:
- Presence of other chronic concomitant disease
- Presence of other autoimmune disease
- Presence of sleep disturbance
- Abuse of alcohol and other drugs
- Pregnancy or lactation, climacteric and/or menopausal women
- Adherence to extreme diet (e.g. macrobiotic or vegetarian diet)
- Celiac disease
- Presence of extensive resection of the small intestine (more than 100cm²)
- Patients undergoing vitamin D replacement for the last 6 months.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Fatigue
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Disorder of Bone Density and Structure, Unspecified
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Sarcopenia
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Vitamin D Deficiency
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Crohn Disease
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Muscle Weakness
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Intervention(s)
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Dietary Supplement: Vitamin D
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Other: Placebo
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Primary Outcome(s)
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Increase in the grip strength in patients with Crohn under vitamin D supplementation
[Time Frame: After 6 months of supplementation with vitamin D]
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Secondary Outcome(s)
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Increase in exercise capacity assessed by Shuttle Walk Test (SWT)
[Time Frame: After 6 months of supplementation with vitamin D]
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Global reduction in laboratorial inflammatory biomarkers (CRP)
[Time Frame: After 6 months of supplementation with vitamin D]
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Reduction in fatigue perception in patients with Crohn under vitamin D supplementation
[Time Frame: After 6 months of supplementation with vitamin D]
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Increase in mineral bone density (MBD)
[Time Frame: After 6 months of supplementation with vitamin D]
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Increase in lean body mass in patients with Crohn under vitamin D supplementation
[Time Frame: After 6 months of supplementation with vitamin D]
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Decrease in fecal Calprotectin levels
[Time Frame: After 6 months of supplementation with vitamin D]
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Global reduction in laboratorial inflammatory biomarkers (TNF-a)
[Time Frame: After 6 months of supplementation with vitamin D]
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Global reduction in laboratorial inflammatory biomarkers (IL 17)
[Time Frame: After 6 months of supplementation with vitamin D]
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Global reduction in laboratorial inflammatory biomarkers (IL 6)
[Time Frame: After 6 months of supplementation with vitamin D]
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Secondary ID(s)
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CAAE41674814500005147
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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