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Completed

NCT Number: NCT01952483

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

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AUBMC Multiple Sclerosis Center

Beirut, Riad El Solh, 11-0236, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Treatment with immune modulating/ suppressive drugs other than IFN-b within 6 weeks prior to enrolment
  • Pregnancy
  • Hypercalcemia
  • eglomerular filtration rate<60
  • History of primary hyperparathyroidism, hypercalcemia, renal dysfunction, cardiac disease, malignancy, or granulomatous disease
  • The 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 abuse/dependence, alcohol abuse/dependence
  • Currently, on any of the following medications Lithium, or Thiazide diuretics

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Sep 30, 2013
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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