Multiple SclerosisNCT03610139
Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients
A study testing Vitamin D3 in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
This is a longitudinal single blind randomized trial to test the effects of high compared to low dose vitamin D3 supplementation on cognitive performance at 6 and 12 months, and MRI measures of 12 months duration. A cognitive assessment battery will be administered at baseline, 6 and 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Clinically Isolated Syndrome
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteLebanon
- Study dates
- 21 May 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Nehme & Therese Tohme Multiple Sclerosis Center
Beirut, 1107 2020
Samia Khoury, MD, +961-1-350000 ext. 7420, sk88@aub.edu.lb
Hala Darwish, PhD, RN
About this study
Official title: Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients: A Single-Blind Randomized Clinical Trial
This is a longitudinal single blind randomized trial to test the effects of high compared to low dose vitamin D3 supplementation on cognitive performance at 6 and 12 months, and MRI measures of 12 months duration. A cognitive assessment battery will be administered at baseline, 6 and 12 months. Related clinical data and information on depression and anxiety, lifestyle, and food sources of vitamin D and sun exposure among other variables will also be collected.
Read the detailed description
Background: Multiple Sclerosis is strongly associated with low serum 25 hydroxy-vitamin-D (25(OH)D) and impaired cognitive performance. In our previous research, participants with low serum 25OHD levels showed significant improvements in visuo-spatial memory delayed recall after 3 months of vitamin D3 supplementation. In addition, serum 25(OH)D was significantly associated with this memory function at baseline and at 3 months. Therefore, the aim of this proposed study is 1) to evaluate the long-term effects 6 and 12 months of high (50,000 IU weekly then 10,000 IU weekly) compared to low dose (800 IU daily) vitamin D3 replacement on cognitive function in MS, and 2) to correlate it with the MRI brain measurements of the hippocampus and the frontal cortex volumes, as well as brain parenchymal fraction, and cerebellum. The investigators will then explore these MRI measures in MS patients with deficient 25(OH)D levels at baseline and at 12 months, and correlate it with their cognitive performance.
Methods: This is a longitudinal single blind randomized trial to test the effects of high compared to low dose vitamin D3 supplementation on cognitive performance at 6 and 12 months, and MRI measures of 12 months duration. A cognitive assessment battery, comprised of the Montreal Cognitive Assessment (only at baseline), Stroop, Symbol Digit Modalities Test, Brief Visual Memory Test, and Verbal Memory Test in Arabic, will be administered at baseline, 6 and 12 months. Related clinical data and information on depression and anxiety, lifestyle, and food sources of vitamin D and sun exposure among other variables will also be collected.
Expected results: MS patients with serum 25(OH)D deficiency who receive high dose vitamin D3 supplementation will demonstrate decreased cognitive impairment at 6 and 12 months post supplementation when compared to those who received low vitamin D3 dose and to their pre-supplementation status. The MRI findings are expected to be associated with cognitive performance at baseline, and serum 25(OH)D levels at baseline, and 12 months.
- Conditions
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Clinically Isolated Syndrome, Clinically Isolated Syndrome, CNS Demyelinating, Vitamin D3 Deficiency
- Being tested
- Vitamin D3
- Keywords
- cognitive performance, vitamin D3 replacement, Lebanon
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
At baseline, patients with deficient 25(OH)D levels will be randomly assigned 1:1 to receive either the high dose or standard dose vitamin D supplementation.
| Study group | Role | What they receive |
|---|---|---|
| low dose vitamin D3 supplementation | Active comparator | Patients in this group will take 800 IU daily dose of vitamin D supplementation. They will be kept on 800 IU for 6 months. If they still had low vitamin D at 3 months, they will be asked about their adherence to the supplement, the investigators will remind them to take it as prescribed, and the investigators will keep the 800 IU vitamin D supplement dose for another 3 months. If they were still deficient at 6 months, the investigators will switch them to 10,000 IU weekly dose. Receives: Dietary Supplement: Vitamin D3 |
| high dose vitamin D3 supplementation | Experimental | Patients in this group will take 50,000 IU weekly dose of vitamin D supplementation. Patients who will reach normal serum vitamin D level, between 40-80 ng/ml, at 3 or 6 months will be asked to decrease their Vitamin D3 supplementation as follows: Those who will reach levels between 40-60ng/ml will be switched to 10,000 IU three times per week, and those who reach levels between 60-80 ng/ml will be switched to 10,000 IU once weekly.
If they did not have any improvement in their levels of vitamin D at 3 or 6 months, they will be asked about their adherence to the supplement and the investigators will remind them to take it as prescribed and the investigators will keep them at the 50,000 IU weekly dose. Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Brief Visuospatial Memory Test-Revised (BVMT-R) scores at 6 months
It is a visuospatial memory test that is comprised of three memory trials (10 seconds each) followed by delayed recall trial after 25 minutes. It has been widely used as a quick measure of memory at bedside and in MS patients. The minimum score on each trial is 0 and the maximum score on each trial is 12. Higher values represent a better outcome.
Measured: 6 months
Change from Baseline Arabic Verbal Memory Test (VMAT) scores at 6 months
It is a verbal memory test. It consists of 45 words that are distributed among 3 lists (List A, List B, and a Recognition List). Lists A and B are each composed of 15 words belonging to 3 semantic categories: vegetables, animals, and stationary. The recognition list is composed 45 words that include homonyms, shared or related words and unrelated words with respect to the previous two lists. The VMAT is administered as follows: List A Immediate Free Recall (5 trials) - List B Immediate Free Recall Trial - List A Short Delay Free Recall Trial - List A Short Delay Cued Recall Trial - List A Long Delay Free Recall Trial - List A Long Delay Cued Recall Trial. After 25 minutes of the last trial, List A Delayed Recognition Trial is administered. For each trial, the minimum total score is 0 and the maximum total score is 15. Higher scores represent a better outcome. For each trial except the recognition trial, repeated and intrusive words are counted separately.
Measured: 6 months
Change from Baseline Symbol Digit Modalities Test (SDMT) scores at 6 months
It is a known and widely used speed of processing test. Oral SDMT will be administered; it does not require translation and has been used in Lebanon before. It consists of one trial. The minimum total score is 0 and the maximum total score is 110. Higher scores represent a better outcome.
Measured: 6 months
Change from Baseline Stroop test scores at 6 months
It is a highly established test of attention. Subject is given a list of colors in black ink to read (Stroop 1), then a list of colors in their corresponding ink color (Stroop 2), and then finally a list of colors with incongruent ink colors (Stroop 3), the participant is expected to read the word without being affected by interfering mismatching color. The number of words read in a minute (minus the errors) is the dependent measure and interference will be calculated using the following equation: Interference = Stroop 3 - [(Stroop 1+Stroop 2)/2]. For each of the 3 lists, the minimum total score is 0 and the maximum total score is 100. Higher scores represent a better outcome. For the interference, the minimum score is -100 and the maximum score is 0. Higher scores represent a better outcome.
Measured: 6 months
Change from Baseline Brief Visuospatial Memory Test-Revised (BVMT-R) scores at 12 months
It is a visuospatial memory test that is comprised of three memory trials (10 seconds each) followed by delayed recall trial after 25 minutes. It has been widely used as a quick measure of memory at bedside and in MS patients. The minimum score on each trial is 0 and the maximum score on each trial is 12. Higher values represent a better outcome.
Measured: 12 months
Change from Baseline Arabic Verbal Memory Test (VMAT) scores at 12 months
It is a verbal memory test. It consists of 45 words that are distributed among 3 lists (List A, List B, and a Recognition List). Lists A and B are each composed of 15 words belonging to 3 semantic categories: vegetables, animals, and stationary. The recognition list is composed 45 words that include homonyms, shared or related words and unrelated words with respect to the previous two lists. The VMAT is administered as follows: List A Immediate Free Recall (5 trials) - List B Immediate Free Recall Trial - List A Short Delay Free Recall Trial - List A Short Delay Cued Recall Trial - List A Long Delay Free Recall Trial - List A Long Delay Cued Recall Trial. After 25 minutes of the last trial, List A Delayed Recognition Trial is administered. For each trial, the minimum total score is 0 and the maximum total score is 15. Higher scores represent a better outcome. For each trial except the recognition trial, repeated and intrusive words are counted separately.
Measured: 12 months
Change from Baseline Symbol Digit Modalities Test (SDMT) scores at 12 months
It is a known and widely used speed of processing test. Oral SDMT will be administered; it does not require translation and has been used in Lebanon before. It consists of one trial. The minimum total score is 0 and the maximum total score is 110. Higher scores represent a better outcome.
Measured: 12 months
Change from Baseline Stroop test scores at 12 months
It is a highly established test of attention. Subject is given a list of colors in black ink to read (Stroop 1), then a list of colors in their corresponding ink color (Stroop 2), and then finally a list of colors with incongruent ink colors (Stroop 3), the participant is expected to read the word without being affected by interfering mismatching color. The number of words read in a minute (minus the errors) is the dependent measure and interference will be calculated using the following equation: Interference = Stroop 3 - [(Stroop 1+Stroop 2)/2]. For each of the 3 lists, the minimum total score is 0 and the maximum total score is 100. Higher scores represent a better outcome. For the interference, the minimum score is -100 and the maximum score is 0. Higher scores represent a better outcome.
Measured: 12 months
Secondary outcomes (4)
Change from Baseline Magnetic Resonance Imaging Brain Markers of the Hippocampus volume at 12 months
Changes in baseline MRI brain measurements of the hippocampus volume will be assessed at 12 months.
Measured: 12 months
Change from Baseline Magnetic Resonance Imaging Brain Markers of the frontal cortex volume at 12 months
Changes in baseline MRI brain measurements of the frontal cortex volumes will be assessed 12 months.
Measured: 12 months
Change from Baseline Magnetic Resonance Imaging Brain Markers of the brain parenchymal fraction at 12 months
Changes in baseline MRI brain measurements of the brain parenchymal fraction will be assessed at 12 months.
Measured: 12 months
Change from Baseline Magnetic Resonance Imaging Brain Markers of the Cerebellum at 12 months
Changes in baseline MRI brain measurements of the cerebellum will be assessed at 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start21 May 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Darwish, American University of Beirut Medical Center
- Investigators
- Hala Darwish, PhD, RN, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610139
- Sponsor's protocol ID
- BIO-2017-0395
- Status last verified
- Aug 2021
- First submitted
- 13 Jul 2018
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Darwish H, Haddad R, Osman S, Ghassan S, Yamout B, Tamim H, Khoury S. Effect of Vitamin D Replacement on Cognition in Multiple Sclerosis Patients. Sci Rep. 2017 Apr 4;7:45926. doi: 10.1038/srep45926.
PubMed 28374837Balion C, Griffith LE, Strifler L, Henderson M, Patterson C, Heckman G, Llewellyn DJ, Raina P. Vitamin D, cognition, and dementia: a systematic review and meta-analysis. Neurology. 2012 Sep 25;79(13):1397-405. doi: 10.1212/WNL.0b013e31826c197f.
PubMed 23008220Darwish H, Zeinoun P, Ghusn H, Khoury B, Tamim H, Khoury SJ. Serum 25-hydroxyvitamin D predicts cognitive performance in adults. Neuropsychiatr Dis Treat. 2015 Aug 25;11:2217-23. doi: 10.2147/NDT.S87014. eCollection 2015.
PubMed 26346368van der Schaft J, Koek HL, Dijkstra E, Verhaar HJ, van der Schouw YT, Emmelot-Vonk MH. The association between vitamin D and cognition: a systematic review. Ageing Res Rev. 2013 Sep;12(4):1013-23. doi: 10.1016/j.arr.2013.05.004. Epub 2013 May 29.
PubMed 23727408
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients: A Single-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03610139
- Acronym / sponsor ID
- BIO-2017-0395
- Conditions
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Clinically Isolated Syndrome, Clinically Isolated Syndrome, CNS Demyelinating, Vitamin D3 Deficiency
- Keywords
- cognitive performance, vitamin D3 replacement, Lebanon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a longitudinal single blind randomized trial to test the effects of high compared to low dose vitamin D3 supplementation on cognitive performance at 6 and 12 months, and MRI measures of 12 months duration. A cognitive assessment battery will be administered at baseline, 6 and 12 months. Related clinical data and information on depression and anxiety, lifestyle, and food sources of vitamin D and sun exposure among other variables will also be collected.
Detailed description
Background: Multiple Sclerosis is strongly associated with low serum 25 hydroxy-vitamin-D (25(OH)D) and impaired cognitive performance. In our previous research, participants with low serum 25OHD levels showed significant improvements in visuo-spatial memory delayed recall after 3 months of vitamin D3 supplementation. In addition, serum 25(OH)D was significantly associated with this memory function at baseline and at 3 months. Therefore, the aim of this proposed study is 1) to evaluate the long-term effects 6 and 12 months of high (50,000 IU weekly then 10,000 IU weekly) compared to low dose (800 IU daily) vitamin D3 replacement on cognitive function in MS, and 2) to correlate it with the MRI brain measurements of the hippocampus and the frontal cortex volumes, as well as brain parenchymal fraction, and cerebellum. The investigators will then explore these MRI measures in MS patients with deficient 25(OH)D levels at baseline and at 12 months, and correlate it with their cognitive performance.
Methods: This is a longitudinal single blind randomized trial to test the effects of high compared to low dose vitamin D3 supplementation on cognitive performance at 6 and 12 months, and MRI measures of 12 months duration. A cognitive assessment battery, comprised of the Montreal Cognitive Assessment (only at baseline), Stroop, Symbol Digit Modalities Test, Brief Visual Memory Test, and Verbal Memory Test in Arabic, will be administered at baseline, 6 and 12 months. Related clinical data and information on depression and anxiety, lifestyle, and food sources of vitamin D and sun exposure among other variables will also be collected.
Expected results: MS patients with serum 25(OH)D deficiency who receive high dose vitamin D3 supplementation will demonstrate decreased cognitive impairment at 6 and 12 months post supplementation when compared to those who received low vitamin D3 dose and to their pre-supplementation status. The MRI findings are expected to be associated with cognitive performance at baseline, and serum 25(OH)D levels at baseline, and 12 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose vitamin D3 supplementation | Active comparator | Dietary Supplement: Vitamin D3Patients in this group will take 800 IU daily dose of vitamin D supplementation. They will be kept on 800 IU for 6 months. If they still had low vitamin D at 3 months, they will be asked about their adherence to the supplement, the investigators will remind them to take it as prescribed, and the investigators will keep the 800 IU vitamin D supplement dose for another 3 months. If they were still deficient at 6 months, the investigators will switch them to 10,000 IU weekly dose. |
| high dose vitamin D3 supplementation | Experimental | Dietary Supplement: Vitamin D3Patients in this group will take 50,000 IU weekly dose of vitamin D supplementation. Patients who will reach normal serum vitamin D level, between 40-80 ng/ml, at 3 or 6 months will be asked to decrease their Vitamin D3 supplementation as follows: Those who will reach levels between 40-60ng/ml will be switched to 10,000 IU three times per week, and those who reach levels between 60-80 ng/ml will be switched to 10,000 IU once weekly. If they did not have any improvement in their levels of vitamin D at 3 or 6 months, they will be asked about their adherence to the supplement and the investigators will remind them to take it as prescribed and the investigators will keep them at the 50,000 IU weekly dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3At baseline, patients with deficient 25(OH)D levels will be randomly assigned 1:1 to receive either the high dose or standard dose vitamin D supplementation. | Dietary supplement | high dose vitamin D3 supplementation, low dose vitamin D3 supplementation |
Primary outcome
Change from Baseline Brief Visuospatial Memory Test-Revised (BVMT-R) scores at 6 months
Time frame: 6 months
It is a visuospatial memory test that is comprised of three memory trials (10 seconds each) followed by delayed recall trial after 25 minutes. It has been widely used as a quick measure of memory at bedside and in MS patients. The minimum score on each trial is 0 and the maximum score on each trial is 12. Higher values represent a better outcome.
Change from Baseline Arabic Verbal Memory Test (VMAT) scores at 6 months
Time frame: 6 months
It is a verbal memory test. It consists of 45 words that are distributed among 3 lists (List A, List B, and a Recognition List). Lists A and B are each composed of 15 words belonging to 3 semantic categories: vegetables, animals, and stationary. The recognition list is composed 45 words that include homonyms, shared or related words and unrelated words with respect to the previous two lists. The VMAT is administered as follows: List A Immediate Free Recall (5 trials) - List B Immediate Free Recall Trial - List A Short Delay Free Recall Trial - List A Short Delay Cued Recall Trial - List A Long Delay Free Recall Trial - List A Long Delay Cued Recall Trial. After 25 minutes of the last trial, List A Delayed Recognition Trial is administered. For each trial, the minimum total score is 0 and the maximum total score is 15. Higher scores represent a better outcome. For each trial except the recognition trial, repeated and intrusive words are counted separately.
Change from Baseline Symbol Digit Modalities Test (SDMT) scores at 6 months
Time frame: 6 months
It is a known and widely used speed of processing test. Oral SDMT will be administered; it does not require translation and has been used in Lebanon before. It consists of one trial. The minimum total score is 0 and the maximum total score is 110. Higher scores represent a better outcome.
Change from Baseline Stroop test scores at 6 months
Time frame: 6 months
It is a highly established test of attention. Subject is given a list of colors in black ink to read (Stroop 1), then a list of colors in their corresponding ink color (Stroop 2), and then finally a list of colors with incongruent ink colors (Stroop 3), the participant is expected to read the word without being affected by interfering mismatching color. The number of words read in a minute (minus the errors) is the dependent measure and interference will be calculated using the following equation: Interference = Stroop 3 - [(Stroop 1+Stroop 2)/2]. For each of the 3 lists, the minimum total score is 0 and the maximum total score is 100. Higher scores represent a better outcome. For the interference, the minimum score is -100 and the maximum score is 0. Higher scores represent a better outcome.
Change from Baseline Brief Visuospatial Memory Test-Revised (BVMT-R) scores at 12 months
Time frame: 12 months
It is a visuospatial memory test that is comprised of three memory trials (10 seconds each) followed by delayed recall trial after 25 minutes. It has been widely used as a quick measure of memory at bedside and in MS patients. The minimum score on each trial is 0 and the maximum score on each trial is 12. Higher values represent a better outcome.
Change from Baseline Arabic Verbal Memory Test (VMAT) scores at 12 months
Time frame: 12 months
It is a verbal memory test. It consists of 45 words that are distributed among 3 lists (List A, List B, and a Recognition List). Lists A and B are each composed of 15 words belonging to 3 semantic categories: vegetables, animals, and stationary. The recognition list is composed 45 words that include homonyms, shared or related words and unrelated words with respect to the previous two lists. The VMAT is administered as follows: List A Immediate Free Recall (5 trials) - List B Immediate Free Recall Trial - List A Short Delay Free Recall Trial - List A Short Delay Cued Recall Trial - List A Long Delay Free Recall Trial - List A Long Delay Cued Recall Trial. After 25 minutes of the last trial, List A Delayed Recognition Trial is administered. For each trial, the minimum total score is 0 and the maximum total score is 15. Higher scores represent a better outcome. For each trial except the recognition trial, repeated and intrusive words are counted separately.
Change from Baseline Symbol Digit Modalities Test (SDMT) scores at 12 months
Time frame: 12 months
It is a known and widely used speed of processing test. Oral SDMT will be administered; it does not require translation and has been used in Lebanon before. It consists of one trial. The minimum total score is 0 and the maximum total score is 110. Higher scores represent a better outcome.
Change from Baseline Stroop test scores at 12 months
Time frame: 12 months
It is a highly established test of attention. Subject is given a list of colors in black ink to read (Stroop 1), then a list of colors in their corresponding ink color (Stroop 2), and then finally a list of colors with incongruent ink colors (Stroop 3), the participant is expected to read the word without being affected by interfering mismatching color. The number of words read in a minute (minus the errors) is the dependent measure and interference will be calculated using the following equation: Interference = Stroop 3 - [(Stroop 1+Stroop 2)/2]. For each of the 3 lists, the minimum total score is 0 and the maximum total score is 100. Higher scores represent a better outcome. For the interference, the minimum score is -100 and the maximum score is 0. Higher scores represent a better outcome.
4 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Background: PubMed 28374837Darwish H, Haddad R, Osman S, Ghassan S, Yamout B, Tamim H, Khoury S. Effect of Vitamin D Replacement on Cognition in Multiple Sclerosis Patients. Sci Rep. 2017 Apr 4;7:45926. doi: 10.1038/srep45926.
- Background: PubMed 23008220Balion C, Griffith LE, Strifler L, Henderson M, Patterson C, Heckman G, Llewellyn DJ, Raina P. Vitamin D, cognition, and dementia: a systematic review and meta-analysis. Neurology. 2012 Sep 25;79(13):1397-405. doi: 10.1212/WNL.0b013e31826c197f.
- Background: PubMed 26346368Darwish H, Zeinoun P, Ghusn H, Khoury B, Tamim H, Khoury SJ. Serum 25-hydroxyvitamin D predicts cognitive performance in adults. Neuropsychiatr Dis Treat. 2015 Aug 25;11:2217-23. doi: 10.2147/NDT.S87014. eCollection 2015.
- Background: PubMed 23727408van der Schaft J, Koek HL, Dijkstra E, Verhaar HJ, van der Schouw YT, Emmelot-Vonk MH. The association between vitamin D and cognition: a systematic review. Ageing Res Rev. 2013 Sep;12(4):1013-23. doi: 10.1016/j.arr.2013.05.004. Epub 2013 May 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hala Darwish, PhD, RN principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hala Darwish, PhD, RN (+961-1-350000 ext. 7427, hd30@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Brief Visuospatial Memory Test-Revised (BVMT-R) scores at 6 months (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03610139, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.