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

NCT02704624 | Unknown Phase 4 DMC

• 1 other identifier: CAAE41674814500005147
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Vitamin D Deficiency; Fatigue; Sarcopenia; Muscle Weakness; Disorder of Bone Density and Structure, Unspecified

Keywords

Crohn Disease; Fatigue; Osteopenia; Exercise Tolerance; Vitamin d

Outcome Measures

Primary Outcomes (1)

• Increase in the grip strength in patients with Crohn under vitamin D supplementation

  Grip strength will be expressed in kg

  After 6 months of supplementation with vitamin D

Secondary Outcomes (9)

• Increase in mineral bone density (MBD)

  After 6 months of supplementation with vitamin D

• Decrease in fecal Calprotectin levels

  After 6 months of supplementation with vitamin D

• Global reduction in laboratorial inflammatory biomarkers (TNF-α)

  After 6 months of supplementation with vitamin D

• Increase in exercise capacity assessed by Shuttle Walk Test (SWT)

  After 6 months of supplementation with vitamin D

• Increase in lean body mass in patients with Crohn under vitamin D supplementation

  After 6 months of supplementation with vitamin D

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Tablets with 50000UI cholecalciferol (vitamin D3) will be administered, weekly, for six months.

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

The patients selected to the placebo group will receive inert content tablets without therapeutic effect, weekly, for six months.

Other: Placebo

Interventions

Vitamin D DIETARY_SUPPLEMENT

investigate the relationship between musculoskeletal manifestations, in Crohn population, and the hypovitaminosis D

Vitamin D

Placebo OTHER

compare the musculoskeletal manifestations of the Placebo group with the group receiving Vitamin D

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of Crohn's Disease (moderate to severe)
• Remission of Crohn's activity
• Reduced blood levels of vitamin D

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Juiz de Fora: lead
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator

Study Sites (1)

Universidade Federal de Juiz de Fora

Juiz de Fora, Minas Gerais, Brazil

Location

Related Publications (16)

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MeSH Terms

Conditions

Crohn Disease; Vitamin D Deficiency; Fatigue; Sarcopenia; Muscle Weakness; Bone Diseases, Metabolic

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes; Bone Diseases; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Júlio MF Chebli, Professor

  Federal University of Juiz de Fora

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 10, 2016
• Study Start: December 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: February 1, 2022
• Last Updated: June 29, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)