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

NCT01005095 | Terminated Phase 4

• 1 other identifier: RNFVD0209
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

MULTIPLE SCLEROSIS

Outcome Measures

Primary Outcomes (1)

• Occurrence and severity of Interferon beta related Flu Like Symptoms and Injection Site Reactions.

  One year

Secondary Outcomes (7)

• Expanded Disability Status Scale (EDSS) progression

  1 year

• Relapse rate

  1 year

• Quality of life

  1 year

• Change in serum levels of cytokines and proteins involved in MS pathogenesis

  12 months

• Immune cells subsets

  6 months

Study Arms (2)

High dose vitamin D

EXPERIMENTAL

800 IU of Vitamin D3 by tablets plus a bottle of 75,000 IU vitamin D3 solution every 3 weeks

Dietary Supplement: Vitamin D3

Low dose vitamin D

ACTIVE COMPARATOR

800 IU of vitamin D3 by tablets plus a 3 weekly placebo solution

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

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

High dose vitamin D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

MS Clinic, Carmel Medical Center

Haifa, Israel, Israel

Location

Related Publications (1)

• Golan D, Halhal B, Glass-Marmor L, Staun-Ram E, Rozenberg O, Lavi I, Dishon S, Barak M, Ish-Shalom S, Miller A. Vitamin D supplementation for patients with multiple sclerosis treated with interferon-beta: a randomized controlled trial assessing the effect on flu-like symptoms and immunomodulatory properties. BMC Neurol. 2013 Jun 14;13:60. doi: 10.1186/1471-2377-13-60.

  PMID: 23767916 DERIVED

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

• Ariel Miller, Prof

  Multiple Sclerosis Center Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: October 30, 2009
• Study Start: October 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: September 5, 2012

Record last verified: 2012-09

Locations

IL (1)