Clinical Research Details

Descriptive Information
Effect of Vitamin D replacement on immune function and cognition in MS patients

Samia Khoury


Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 2  

  • Hala Darwish
Conditions and Keywords
Multiple Sclerosis
Multiple Sclerosis
Study Design
Other: Describe in Detailed Description
To compare the immune responses in patients with Vitamin D deficiency (serum level <25µg/ml) to those of patients with normal Vitamin D (serum level >35 µg/ml). To measure cognitive performance in patients with Vitamin D deficiency (serum level <25µg/ml) compared to those of patients with normal Vitamin D (serum level >35 µg/ml) after adjusting for educational levels and disease duration.
N/A: Not Applicable
N/A: Not Applicable
N/A: Not Applicable
N/A: Not Applicable
Case Control
Eligibility and IRB
Min: 18

This is a prospective, non-interventional study of pre- and post-vitamin D high dose supplementation.
Baseline blood samples will be collected from all participating MS patients for vitamin D testing and immunological assays. Those with deficient vitamin D will be given a high dose vitamin D supplementation as per usual clinical practice. Those with normal vitamin D levels will maintain their usual care. Patient's immune and cognitive function at baseline and after 3 months will also be measured. Subjects will be handed a diary on which they will document their ingestion of food known to be rich in vitamin D.

Multiple Sclerosis patients visiting the MS Center

Non-probabilty sampling

Clinically Isolated Syndrome and MS patients diagnosed according to the McDonald 2010 criteria, treated with interferon beta, and not showing signs of active inflammation.

- Treatment with immune modulating/suppressive drugs other than interferon beta within 6 weeks prior to enrollment

- Pregnancy

- Hypercalcemia

- eGFR<60

- History of primaty hyperparathyrodism, hypercalcemia, renal dysfunction, cardiac disease, malignancy, granulomatous disease

- Occurrence of an exacerbation (defined as an episode of neurologic dysfunction lasting at least 24 hours) within 4 weeks of enrollment

- History of dementia or related disorders

- History of traumatic brain injury

- Diagnosis of epilepsy or history of seizure

- Diagnosis of psychiatric disease, substance or alcohol abuse/dependence

- Currently on Lithium or Thiazide diuretics