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Effect of Vitamin D Replacement on Immune Function and Cognition in MS Patients

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ClinicalTrials.gov Identifier: NCT01952483
Recruitment Status : Completed
First Posted : September 30, 2013
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Samia Khoury, American University of Beirut Medical Center

Brief Summary:

Assessing the immune activation in MS patients deficient in Vitamin D and whether Vitamin D supplementation reverse the immune activation

Evaluating whether Vitamin D deficiency result in lower cognitive performance in MS patients and the effect of Vitamin D supplementation on reversing the cognitive impairment?


Condition or disease
Multiple Sclerosis (MS)

Detailed Description:

We will compare the immune responses in patients with Vitamin D deficiency (serum level <20ng/ml) to those of patients with normal Vitamin D (serum level >35 ng/ml). We will focus on proliferation and cytokine production to myelin basic protein (MBP) and myelin oligodendrocyte glycoprotein (MOG) peptides and on the percentage of Th1 (IFN gamma producing cells) and Th17 (IL-17 producing cells) during in vitro polarization assays. Our hypothesis is that patients with low Vitamin D have increase proliferation to MBP and MOG and increased production of pro-inflammatory cytokines (IFN gamma and IL-17) and that Vitamin D supplementation will decrease this pro-inflammatory profile.

We will measure cognitive performance in patients with Vitamin D deficiency (serum level <20ng/ml) compared to those of patients with normal Vitamin D (serum level >35 ng/ml) after adjusting for educational levels and disease duration. We hypothesize that low Vitamin D has a negative effect on cognitive performance and that Vitamin D supplementation will improve cognitive function.


Study Type : Observational [Patient Registry]
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Effect of Vitamin D Replacement on Immune Function and Cognition in MS Patients
Study Start Date : August 2012
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Group/Cohort
vitamin D deficient,
Vitamin D deficiency (serum level <20ng/ml)
Vitamin D normal
Serum level >35 ng/ml



Primary Outcome Measures :
  1. Is there evidence of immune activation in MS patients deficient in Vitamin D and does Vitamin D supplementation reverse the immune activation? [ Time Frame: 3months ]
    We will compare the immune responses in patients with Vitamin D deficiency (serum level <20ng/ml) to those of patients with normal Vitamin D (serum level >35 µg/ml). We will focus on proliferation and cytokine production to myelin basic protein (MBP) and myelin oligodendrocyte glycoprotein (MOG) peptides and on the percentage of Th1 (IFN gamma producing cells) and Th17 (IL-17 producing cells) during in vitro polarization assays. Our hypothesis is that patients with low Vitamin D have increase proliferation to MBP and MOG and increased production of pro-inflammatory cytokines (IFN gamma and IL-17) and that Vitamin D supplementation will decrease this pro-inflammatory profile.


Secondary Outcome Measures :
  1. Does Vitamin D deficiency result in lower cognitive performance in MS patients and does Vitamin D supplementation reverse the cognitive impairment? [ Time Frame: 3 months ]
    We will measure cognitive performance in patients with Vitamin D deficiency (serum level <20ng/ml) compared to those of patients with normal Vitamin D (serum level >35 ng/ml) after adjusting for educational levels and disease duration. We hypothesize that low Vitamin D has a negative effect on cognitive performance and that Vitamin D supplementation will improve cognitive function.


Biospecimen Retention:   Samples Without DNA
We will focus on proliferation and cytokine production to myelin basic protein (MBP) and myelin oligodendrocyte glycoprotein (MOG) peptides and on the percentage of Th1 (IFN gamma producing cells) and Th17 (IL-17 producing cells) during in vitro polarization assays


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Group 1: low vitamin D (less than 25 ng/ml) Group 2: normal vitamin D level (greater than 35 ng/ ml)
Criteria

Inclusion Criteria:

  1. Definite diagnosis of Multiple Sclerosis following the revised McDonald MS diagnostic criteria
  2. Male and Female Aged 18 and above
  3. On interferon-β treatment (Rebif®, Avonex®, or Betaseron®)
  4. No signs of active inflammation or attack or new lesions on MRI

Exclusion Criteria:

  1. Treatment with immune modulating/ suppressive drugs other than IFN-b within 6 weeks prior to enrolment
  2. Pregnancy
  3. Hypercalcemia
  4. eglomerular filtration rate<60
  5. History of primary hyperparathyroidism, hypercalcemia, renal dysfunction, cardiac disease, malignancy, or granulomatous disease
  6. The occurrence of an exacerbation (defined as an episode of neurologic dysfunction lasting at least 24 hours) within 4 weeks of enrollment
  7. History of dementia or related disorders
  8. History of traumatic brain injury
  9. Diagnosis of epilepsy or history of seizure
  10. Diagnosis of psychiatric disease, substance abuse/dependence, alcohol abuse/dependence
  11. Currently, on any of the following medications Lithium, or Thiazide diuretics

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): NCT01952483


Locations
Lebanon
AUBMC Multiple Sclerosis Center
Beirut, Riad El Solh, Lebanon, 11-0236
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
Principal Investigator: Samia J Khoury, professor AUBMC

Publications:
Responsible Party: Samia Khoury, Professor, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT01952483     History of Changes
Other Study ID Numbers: IM.SK1.04
First Posted: September 30, 2013    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Samia Khoury, American University of Beirut Medical Center:
Multiple Sclerosis (MS)

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents