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The Effects of Interferon Beta Combined With Vitamin D on Relapsing Remitting Multiple Sclerosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01005095
Recruitment Status : Terminated (Interim analysis showed that the odds for proving primary hypothesis are low.)
First Posted : October 30, 2009
Last Update Posted : September 5, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
MULTIPLE SCLEROSIS Dietary Supplement: Vitamin D3 Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : October 2010
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Occurrence and severity of Interferon beta related Flu Like Symptoms and Injection Site Reactions. [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Expanded Disability Status Scale (EDSS) progression [ Time Frame: 1 year ]
  2. Relapse rate [ Time Frame: 1 year ]
  3. Quality of life [ Time Frame: 1 year ]
  4. Change in serum levels of cytokines and proteins involved in MS pathogenesis [ Time Frame: 12 months ]
  5. Immune cells subsets [ Time Frame: 6 months ]
  6. Night time Urine levels of 6-sulphatoxy-melatonin [ Time Frame: 1 year ]
  7. Percent rise of IL6 and TRAIL levels following IFN-beta injection [ Time Frame: 3 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01005095     History of Changes
Other Study ID Numbers: RNFVD0209
First Posted: October 30, 2009    Key Record Dates
Last Update Posted: September 5, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pharmaceutical Solutions
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Interferons
Interferon-beta
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors