Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 7 September 2021
• Main ID: NCT03610139
• Date of registration: 13/07/2018
• Prospective Registration: No
• Primary sponsor: American University of Beirut Medical Center
• Public title: Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients
• Scientific title: Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients: A Single-Blind Randomized Clinical Trial
• Date of first enrolment: May 21, 2018
• Target sample size: 162
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03610139
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Lebanon

Contacts

• Name: Hala Darwish, PhD, RN
• Affiliation: American University of Beirut Medical Center

• Name: Hala Darwish, PhD, RN

• Name: Samia Khoury, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed informed consent form

- Males/ Females

- Age = 18 years old

- Have a definite diagnosis of RRMS as per the revised McDonald 2010 or CIS.

- Untreated or on any MS therapy

- Showed no clinical evidence of relapses during the past month and disease duration not
greater than 10 years.

- Subjects who have a serum vitamin D level below 25 ng/ml

Exclusion Criteria:

- All subjects using drugs associated with hypercalcemia.

- Pregnant and with history of primary hyper PTH.

- Subjects with hypercalcemia, renal dysfunction, malignancy, or granulomatous disease,
dementia, traumatic brain injury, diagnosis of epilepsy or history of seizure,
psychiatric disease other than anxiety and depression, or are found to be suicidal on
screening, or taking psychoactive medications other than antidepressants

- Subjects who have a serum vitamin D level above 25 ng/ml

- Subjects who have not done an MRI scan up to 3 months before or after the baseline
visit.

- Subjects who have a history of kidney stones

- Subjects with malabsorption

- Individuals with history of alcohol abuse/dependence and/or substance
use/abuse/dependence will also be excluded from the study. Men who consume more than
15 drinks per week and women who consume more than eight drinks per week will be
considered excessive alcohol consumers and will be excluded from the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Vitamin D3 Deficiency

Multiple Sclerosis

Clinically Isolated Syndrome, CNS Demyelinating

Clinically Isolated Syndrome

Intervention(s)

Dietary Supplement: Vitamin D3

Primary Outcome(s)

Change from Baseline Arabic Verbal Memory Test (VMAT) scores at 6 months [Time Frame: 6 months]

Change from Baseline Symbol Digit Modalities Test (SDMT) scores at 12 months [Time Frame: 12 months]

Change from Baseline Symbol Digit Modalities Test (SDMT) scores at 6 months [Time Frame: 6 months]

Change from Baseline Brief Visuospatial Memory Test-Revised (BVMT-R) scores at 12 months [Time Frame: 12 months]

Change from Baseline Brief Visuospatial Memory Test-Revised (BVMT-R) scores at 6 months [Time Frame: 6 months]

Change from Baseline Stroop test scores at 6 months [Time Frame: 6 months]

Change from Baseline Arabic Verbal Memory Test (VMAT) scores at 12 months [Time Frame: 12 months]

Change from Baseline Stroop test scores at 12 months [Time Frame: 12 months]

Secondary Outcome(s)

Change from Baseline Magnetic Resonance Imaging Brain Markers of the brain parenchymal fraction at 12 months [Time Frame: 12 months]

Change from Baseline Magnetic Resonance Imaging Brain Markers of the Cerebellum at 12 months [Time Frame: 12 months]

Change from Baseline Magnetic Resonance Imaging Brain Markers of the Hippocampus volume at 12 months [Time Frame: 12 months]

Change from Baseline Magnetic Resonance Imaging Brain Markers of the frontal cortex volume at 12 months [Time Frame: 12 months]

Secondary ID(s)

BIO-2017-0395

Source(s) of Monetary Support

Please refer to primary and secondary sponsors