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Effects of Supplementation of Vitamin D in Patients With Crohn's Disease

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ClinicalTrials.gov Identifier: NCT02704624
Recruitment Status : Enrolling by invitation
First Posted : March 10, 2016
Last Update Posted : June 29, 2018
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Information provided by (Responsible Party):
Lorena Nagme de Oliveira Pinto, Federal University of Juiz de Fora

Brief Summary:
Thus, the aim of the current study is to assess the influence of vitamin D deficiency and, consequently, of serum calcium deficiency in the body composition, muscular activity, bone mineral density, fatigue, and exercise tolerance of CD patients. Secondly, it also aims to determine the impact of vitamin D supplementation on this population.

Condition or disease Intervention/treatment Phase
Crohn Disease Vitamin D Deficiency Fatigue Sarcopenia Muscle Weakness Disorder of Bone Density and Structure, Unspecified Dietary Supplement: Vitamin D Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A double-blind, randomized, placebo-controlled study will be performed. After the evaluation of serum vitamin D levels, patients with vitamin D below 30ng/mL will be randomized into two groups. One group will receive supplementation with cholecalciferol (vitamin D3) tablets and the other group will receive placebo. Those will be provided at no cost to the patients. The dosage of 1.500-2.000 IU (International Units) vitamin D/day is recommended in order to meet the need of vitamin D above 30ng/mL in adults. However, a dose at least 2 to 3 times higher is recommended for CD patients due to malabsorption, significant loss of adipose tissue and use of glucocorticoids. Thus, the dose of 50,000IU/week will be administered in a single dose. The patients drawn to the placebo group will receive inert content tablets without therapeutic effect. After the study completion, these control patients will receive complete treatment for hypovitaminosis D.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Only the pharmacist responsible for confection of the tablets will know who will receive vitamin d or placebo, according to a list of randimization generated in the computer by the statistician. The list will be kept with the pharmacist throughout the intervention.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin D
Tablets with 50000UI cholecalciferol (vitamin D3) will be administered, weekly, for six months.
Dietary Supplement: Vitamin D
investigate the relationship between musculoskeletal manifestations, in Crohn population, and the hypovitaminosis D

Placebo Comparator: Placebo
The patients selected to the placebo group will receive inert content tablets without therapeutic effect, weekly, for six months.
Other: Placebo
compare the musculoskeletal manifestations of the Placebo group with the group receiving Vitamin D




Primary Outcome Measures :
  1. Increase in the grip strength in patients with Crohn under vitamin D supplementation [ Time Frame: After 6 months of supplementation with vitamin D ]
    Grip strength will be expressed in kg


Secondary Outcome Measures :
  1. Increase in mineral bone density (MBD) [ Time Frame: After 6 months of supplementation with vitamin D ]
    MBD assessed by DXA, expressed in gr/cm²

  2. Decrease in fecal Calprotectin levels [ Time Frame: After 6 months of supplementation with vitamin D ]
    Levels of calprotectin under 200µg/g

  3. Global reduction in laboratorial inflammatory biomarkers (TNF-α) [ Time Frame: After 6 months of supplementation with vitamin D ]
    TNF-α expressed in pg/ml

  4. Increase in exercise capacity assessed by Shuttle Walk Test (SWT) [ Time Frame: After 6 months of supplementation with vitamin D ]
    Improvement in the distance achieved in the SWT expressed in meters (m)

  5. Increase in lean body mass in patients with Crohn under vitamin D supplementation [ Time Frame: After 6 months of supplementation with vitamin D ]
    Body mass will be assessed by DXA and will be expressed in kg

  6. Reduction in fatigue perception in patients with Crohn under vitamin D supplementation [ Time Frame: After 6 months of supplementation with vitamin D ]
    Fatigue will be measured by the Chalder Fatigue Questionnaire (CFQ). The CFQ is analyzed by 2 domains physical and mental (cutoff: patient's total score higher than 2)

  7. Global reduction in laboratorial inflammatory biomarkers (IL 6) [ Time Frame: After 6 months of supplementation with vitamin D ]
    IL 6 expressed in pg/ml

  8. Global reduction in laboratorial inflammatory biomarkers (IL 17) [ Time Frame: After 6 months of supplementation with vitamin D ]
    IL 17 expressed in pg/ml

  9. Global reduction in laboratorial inflammatory biomarkers (CRP) [ Time Frame: After 6 months of supplementation with vitamin D ]
    CRP expressed in mg/dl



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02704624


Locations
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Brazil
Universidade Federal de Juiz de Fora
Juiz de Fora, Minas Gerais, Brazil
Sponsors and Collaborators
Federal University of Juiz de Fora
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Investigators
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Principal Investigator: Júlio MF Chebli, Professor Federal University of Juiz de Fora
Publications:

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Responsible Party: Lorena Nagme de Oliveira Pinto, lecturer, Federal University of Juiz de Fora
ClinicalTrials.gov Identifier: NCT02704624    
Other Study ID Numbers: CAAE41674814500005147
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lorena Nagme de Oliveira Pinto, Federal University of Juiz de Fora:
Crohn Disease
Fatigue
Osteopenia
Exercise Tolerance
Vitamin d
Additional relevant MeSH terms:
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Muscle Weakness
Bone Diseases
Crohn Disease
Sarcopenia
Vitamin D Deficiency
Fatigue
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Muscular Diseases
Musculoskeletal Diseases
Pathologic Processes
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs