NCT01952483

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 108 (actual)
• Sponsor: American University of Beirut Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

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.

Conditions

• Multiple Sclerosis (MS)

Timeline

• Start date: 2012-08-01
• Primary completion: 2017-05-01
• Completion: 2017-06-30
• First posted: 2013-09-30
• Last updated: 2018-01-11

Locations

1 site across 1 country: Lebanon