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

American University of Beirut Medical Center

Status: Completed

Conditions: Multiple Sclerosis (MS)

Study type: Observational

Funder types: Other

Identifiers

NCT01952483

IM.SK1.04

Details and patient eligibility

About

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?

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

108 participants in 2 patient groups

vitamin D deficient,

Description:

Vitamin D deficiency (serum level \<20ng/ml)

Vitamin D normal

Description:

Serum level \>35 ng/ml