Role of Vitamin D in Reducing the Relapse Rate in Patients With Multiple Sclerosis

NCT01753375 | Unknown Phase 2 DMC

• 1 other identifier: E12816
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Vitamin D3 supplementation reduces the incidence of multiple sclerosis.Although clinical cross-sectional studies have demonstrated vitamin D3 as a positive mediator in preventing relapses and disease progression, prospective randomized control trials are nevertheless necessary to confirm these statements and to determine the most efficacious, safe, and the minimum required doses. This hypothesis is going to be tested through a randomized triple blinded controlled trial in which after randomization, one group of patients will receive vitamin D and second group will receive placebo. Both groups are going to be followed in a similar way over a period of one year with follow ups at 4, 8 and 12 months. Vitamin D levels is going to be performed at 0,4, 12 month interval. MRI is going to be done at the beginning and end of trial.The number of relapses and the physical disability will be calculated through the Expanded disability status scale (EDSS).

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Relapsing rate; Expanded disability status scale; Vitamin D3

Outcome Measures

Primary Outcomes (1)

• Relapse rate in patients with Multiple Sclerosis

  12 months

Secondary Outcomes (1)

• Improvement in the expanded disability status scores after receiving vitamin D3

  12 months

Study Arms (2)

Vitamin D3

ACTIVE COMPARATOR

Administered orally on weekly basis

Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR

To be administered orally on weekly basis

Dietary Supplement: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3 given as 50000 IU orally on weekly basis

Vitamin D3

Placebo DIETARY_SUPPLEMENT

Placebo to be given orally on weekly basis

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18-55 years
• Confirmed Multiple Sclerosis diagnosis according to McDonald criteria
• Stable neurological functioning for at least one month prior to study entry
• Expanded Disability Scale score (EDSS) less than \<\_4.0
• Must have had one clinical attack in past two years and at least one new silent T2 or gadolinium-enhancing lesion on MRI within the past one year.
• Willing to participate for the entire 52-week period

You may not qualify if:

• pregnant or nursing.
• Connective tissue disease (SLE, Sjogren's disease)
• Endocrine disease (hyperthyroidism, hyperparathyroidism)
• Any medical condition predisposing to hypercalcaemia, nephrolithiasis or renal insufficiency

Sponsors & Collaborators

• AlJohara M AlQuaiz, M.D.: lead

Study Sites (1)

Multiple Sclerosis clinic, Department of Neurology, King Khalid Hospital

Riyadh, 231831, Saudi Arabia

Location

Related Publications (7)

• Cantorna MT, Hayes CE, DeLuca HF. 1,25-Dihydroxyvitamin D3 reversibly blocks the progression of relapsing encephalomyelitis, a model of multiple sclerosis. Proc Natl Acad Sci U S A. 1996 Jul 23;93(15):7861-4. doi: 10.1073/pnas.93.15.7861.

  PMID: 8755567 BACKGROUND

• Hayes CE. Vitamin D: a natural inhibitor of multiple sclerosis. Proc Nutr Soc. 2000 Nov;59(4):531-5. doi: 10.1017/s0029665100000768.

  PMID: 11115787 BACKGROUND

• Munger KL, Zhang SM, O'Reilly E, Hernan MA, Olek MJ, Willett WC, Ascherio A. Vitamin D intake and incidence of multiple sclerosis. Neurology. 2004 Jan 13;62(1):60-5. doi: 10.1212/01.wnl.0000101723.79681.38.

  PMID: 14718698 BACKGROUND

• Kimball SM, Ursell MR, O'Connor P, Vieth R. Safety of vitamin D3 in adults with multiple sclerosis. Am J Clin Nutr. 2007 Sep;86(3):645-51. doi: 10.1093/ajcn/86.3.645.

  PMID: 17823429 BACKGROUND

• Shaygannejad V, Janghorbani M, Ashtari F, Dehghan H. Effects of adjunct low-dose vitamin d on relapsing-remitting multiple sclerosis progression: preliminary findings of a randomized placebo-controlled trial. Mult Scler Int. 2012;2012:452541. doi: 10.1155/2012/452541. Epub 2012 Apr 11.

  PMID: 22567287 BACKGROUND

• Jagannath VA, Fedorowicz Z, Asokan GV, Robak EW, Whamond L. Vitamin D for the management of multiple sclerosis. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD008422. doi: 10.1002/14651858.CD008422.pub2.

  PMID: 21154396 BACKGROUND

• Burton JM, Kimball S, Vieth R, Bar-Or A, Dosch HM, Cheung R, Gagne D, D'Souza C, Ursell M, O'Connor P. A phase I/II dose-escalation trial of vitamin D3 and calcium in multiple sclerosis. Neurology. 2010 Jun 8;74(23):1852-9. doi: 10.1212/WNL.0b013e3181e1cec2. Epub 2010 Apr 28.

  PMID: 20427749 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• AlJohara M AlQuaiz, M.D

  King Saud University- Medical college

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Abdulkader Daif, M.D

CONTACT

0966-0504205164; adaif@ksu.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director of "Princess Nora Chair for Women Health Research" , Associate Professor and Consultant Family Physician, Department of Family and Community Medicine

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 20, 2012
• Study Start: January 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 20, 2012

Record last verified: 2012-12

Locations

SA (1)