The Effects of Interferon Beta Combined With Vitamin D on Relapsing Remitting Multiple Sclerosis Patients - Full Text View

Sponsor:	Carmel Medical Center
Information provided by (Responsible Party):	Carmel Medical Center
ClinicalTrials.gov Identifier:	NCT01005095

Purpose

The investigators hypothesize that vitamin D supplementation may ameliorate interferon beta-induced flu-like symptoms, owing to reduced release and activity of the cytokines that are in correlation with this adverse event. Vitamin D supplementation may also positively affect injection site reactions due to its immunomodulatory effects. Vitamin D may also augment the therapeutic efficacy of interferon beta among multiple sclerosis (MS) patients. Vitamin D intake may influence melatonin levels of MS patients as they share the same nuclear receptor.

Condition	Intervention	Phase
MULTIPLE SCLEROSIS	Dietary Supplement: Vitamin D3	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A One Year Prospective, Randomized, Double Blind Interventional Study to Assess Tolerability, Quality of Life and Immunomodulation With Interferon Beta Combined With Vitamin D in Patients With Relapsing Remitting Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis Vitamin D

Drug Information available for: Cholecalciferol Interferon beta Interferon-beta Vitamin D Interferons

U.S. FDA Resources

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:

Occurrence and severity of Interferon beta related Flu Like Symptoms and Injection Site Reactions. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Expanded Disability Status Scale (EDSS) progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Relapse rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change in serum levels of cytokines and proteins involved in MS pathogenesis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Immune cells subsets [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Night time Urine levels of 6-sulphatoxy-melatonin [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Percent rise of IL6 and TRAIL levels following IFN-beta injection [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	October 2010
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: High dose vitamin D 800 IU of Vitamin D3 by tablets plus a bottle of 75,000 IU vitamin D3 solution every 3 weeks	Dietary Supplement: Vitamin D3 Patients will be treated daily with 800 IU of Vitamin D3 by tablets plus a bottle of 75,000 IU vitamin D3 solution every 3 weeks
Active Comparator: Low dose vitamin D 800 IU of vitamin D3 by tablets plus a 3 weekly placebo solution	Dietary Supplement: Vitamin D3 Patients will receive 800 IU of vitamin D3 by tablets plus a 3 weekly placebo solution

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients with a diagnosis of RRMS according to the McDonald criteria (2005)
At least 18 years of age
Patients are treated with IFN-beta for RRMS. The decision to treat with IFN beta will be independent from this study protocol.
Patients will be either newly diagnosed, who are going to start IFN beta therapy for the first time or RRMS patients who suffer from FLS while being treated with IFN beta.
Insufficient blood levels of 25-hydroxy-vitamin D (below 75nmol/l according to current definitions.
EDSS score up to 7
Willing and able to give informed consent

Exclusion Criteria:

Patients having abnormalities of vitamin D related hormonal system other than low dietary intake or decreased sun exposure will be excluded. Namely, malabsorption [Celiac, Whipple, Inflammatory bowl disease, Intestinal bypass surgery, Short bowel syndrome, Cirrhosis, Nephrotic syndrome, Hyperthyroidism, Renal failure [creatinine clearance of less than 40 ml/min], Rickets, Hypoparathyroidism, Hypercalcemia at baseline, known malignancy, granulomatous disorders (Sarcoidosis, Tuberculosis, Silicosis) and Lymphomas.
Patients who take medications that influence vitamin D metabolism, other than corticosteroids, will be also excluded. Namely, Orlistat, Anticonvulsants [Phenobarbital, Primidone, Phenytoin], Rifampin, Isoniazide, ketoconazole, 5FU and Leucovorin
Patients with conditions with increased susceptibility to hypercalcemia will be excluded too: known arrhythmia or heart disease, treatment with Digitalis, or Hydrochlorothiazide.and those who suffer from nephrolithiasis.
Other Central Nervous System disorders than RRMS
Psychiatric disorders such as psychosis, bipolar disorder or substance abuse
Pregnancy
Contra-indication to treatment with IFN-beta

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005095

Locations

Israel
MS Clinic, Carmel Medical Center
Haifa, Israel

Sponsors and Collaborators

Carmel Medical Center

Investigators

Principal Investigator:

Ariel Miller, Prof

Multiple Sclerosis Center Carmel Medical Center

More Information

No publications provided

Responsible Party:	Carmel Medical Center
ClinicalTrials.gov Identifier:	NCT01005095 History of Changes
Other Study ID Numbers:	RNFVD0209
Study First Received:	October 29, 2009
Last Updated:	January 15, 2012
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Cholecalciferol

Vitamin D
Ergocalciferols
Vitamins
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Micronutrients
Growth Substances
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on February 09, 2012