SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT01817166
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
The main objective of this study is to evaluate the efficacy and tolerance of 2 years of
treatment with cholecalciferol (vitamin D3) in patients with a clinically isolated syndrome
at high risk for MS (CIS).
6 Interventions
Name: Vitamin D
Description: Patients will receive 100.000 UI of cholecalciferol every 14 days for a maximum of 24 months or until conversion to full multiple sclerosis has occurred.Type: Drug
Vit D
Name: Placebo
Description: Patients will receive a placebo treatment mimicking 100.000 UI of cholecalciferol every 14 days for a maximum of 24 months or until conversion to full multiple sclerosis has occurred.Type: Drug
Placebo
Name: Imaging
Description: All patients are scheduled for MRI scans at baseline, 3 months, 12 months, 24 months, as well as upon conversion to full MS.Type: Other
Placebo Vit D
Name: Lumbar puncture
Description: A baseline collection of cerebral spinal fluid may be required for certain patients (doctor's decision.)Type: Biological
Placebo Vit D
Name: Blood sampling
Description: Blood sampling is required of all patients at baseline, 3 months, 6 months, 12 months, 18 months and 24 months, as well as upon conversion to MS.Type: Biological
Placebo Vit D
Name: Urine samples
Description: Urine samples are required of all patients at baseline, 3 months, 6 months, 12 months, 18 months, 24 months, and upon conversion to MS.Type: Biological
Placebo Vit D
Primary Outcomes
Description: Conversion to MS according to criteria described by McDonald (Polman et al 2005)
Measure: Conversion to MS yes/no
Time: 24 months
Secondary Outcomes
Measure: Number of relapse episodes (number per year)
Time: 24 months
Measure: number of new brain lesions found in FLAIR MRI or medullary lesions found in T2 MRI
Time: 3 months
Measure: number of new brain lesions found in FLAIR MRI or medullary lesions found in T2 MRI
Time: 12 months
Measure: number of new brain lesions found in FLAIR MRI or medullary lesions found in T2 MRI
Time: 24 months
Description: qualitative variable: 0, 1, or >1
Measure: Number of new T1 lesions taking on Gadolinium highlighting
Time: 3 months
Description: qualitative variable: 0, 1, or >1
Measure: Number of new T1 lesions taking on Gadolinium highlighting
Time: 12 months
Description: qualitative variable: 0, 1, or >1
Measure: Number of new T1 lesions taking on Gadolinium highlighting
Time: 24 months
Measure: Number of hyposignal T1 lesions (black holes)
Time: 3 months
Measure: Number of hyposignal T1 lesions (black holes)
Time: 12 months
Measure: Number of hyposignal T1 lesions (black holes)
Time: 24 months
Measure: Lesional burden in mm^3 for each cerebral MRI
Time: 3 months
Measure: Lesional burden in mm^3 for each cerebral MRI
Time: 12 months
Measure: Lesional burden in mm^3 for each cerebral MRI
Time: 24 months
Description: Exact number (semiautomatic measure)
Measure: Total number of Gadolinium highlighted lesions on T1 images
Time: 3 months
Description: Exact number (semiautomatic measure)
Measure: Total number of Gadolinium highlighted lesions on T1 images
Time: 12 months
Description: Exact number (semiautomatic measure)
Measure: Total number of Gadolinium highlighted lesions on T1 images
Time: 24 months
Description: mm^3
Measure: Normalized cerebral volume (SIENAX) obtained from a T13D sequence
Time: 3 months
Description: mm^3
Measure: Normalized cerebral volume (SIENAX) obtained from a T13D sequence
Time: 12 months
Description: mm^3
Measure: Normalized cerebral volume (SIENAX) obtained from a T13D sequence
Time: 24 months
Measure: Change in global cerebral volume (mm^3)
Time: baseline versus 24 months
Measure: EDSS score, including all subscores
Time: baseline
Measure: EDSS score, including all subscores
Time: 3 months
Measure: EDSS score, including all subscores
Time: 12 months
Measure: EDSS score, including all subscores
Time: 24 months
Measure: EDSS score, including all subscores
Time: after second MS episode (1st relapse)(maximum 24 months)
Measure: score for the PASAT 3 seconds section of the MSFC score
Time: baseline
Measure: score for the PASAT 3 seconds section of the MSFC score
Time: 3 months
Measure: score for the PASAT 3 seconds section of the MSFC score
Time: 12 months
Measure: score for the PASAT 3 seconds section of the MSFC score
Time: 24 months
Measure: score for the PASAT 3 seconds section of the MSFC score
Time: after second MS episode (1st relapse)(maximum 24 months)
Measure: EQ5D questionnaire
Time: baseline
Measure: EQ5D questionnaire
Time: 3 months
Measure: EQ5D questionnaire
Time: 12 months
Measure: EQ5D questionnaire
Time: 24 months
Measure: SF36 questionnaire
Time: baseline
Measure: SF36 questionnaire
Time: 3 months
Measure: SF36 questionnaire
Time: 12 months
Measure: SF36 questionnaire
Time: 24 months
Measure: FSMC fatigue scale
Time: baseline
Measure: FSMC fatigue scale
Time: 3 months
Measure: FSMC fatigue scale
Time: 12 months
Measure: FSMC fatigue scale
Time: 24 months
Measure: TLS-QOL10 questionnaire
Time: baseline
Measure: TLS-QOL10 questionnaire
Time: 3 months
Measure: TLS-QOL10 questionnaire
Time: 12 months
Measure: TLS-QOL10 questionnaire
Time: 24 months
Measure: TLS-Coping10 questionnaire
Time: baseline
Measure: TLS-Coping10 questionnaire
Time: 3 months
Measure: TLS-Coping10 questionnaire
Time: 12 months
Measure: TLS-Coping10 questionnaire
Time: 24 months
Measure: HADS questionnaire
Time: baseline
Measure: HADS questionnaire
Time: 3 months
Measure: HADS questionnaire
Time: 12 months
Measure: HADS questionnaire
Time: 24 months
Description: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.
Measure: Presence/absence of adverse events
Time: baseline
Description: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.
Measure: Presence/absence of adverse events
Time: 3 months
Description: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.
Measure: Presence/absence of adverse events
Time: 6 months
Description: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.
Measure: Presence/absence of adverse events
Time: 12 months
Description: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.
Measure: Presence/absence of adverse events
Time: 18 months
Description: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.
Measure: Presence/absence of adverse events
Time: 24 months
Measure: 25(OH)D2+D3 serum level (nmol/l)
Time: baseline
Measure: 25(OH)D2+D3 serum level (nmol/l)
Time: 3 months
Measure: 25(OH)D2+D3 serum level (nmol/l)
Time: 6 months
Measure: 25(OH)D2+D3 serum level (nmol/l)
Time: 12 months
Measure: 25(OH)D2+D3 serum level (nmol/l)
Time: 18 months
Measure: 25(OH)D2+D3 serum level (nmol/l)
Time: 24 months
Measure: 25(OH)D2+D3 serum level (nmol/l)
Time: upon conversion to MS (maximum 24 months)
Measure: Calciuria/creatinuria
Time: baseline
Measure: Calciuria/creatinuria
Time: 3 months
Measure: Calciuria/creatinuria
Time: 6 months
Measure: Calciuria/creatinuria
Time: 12 months
Measure: Calciuria/creatinuria
Time: 18 months
Measure: Calciuria/creatinuria
Time: 24 months
Measure: Calciuria/creatinuria
Time: upon conversion to MS (maximum 24 months)
Description: The number of days that pass from the beginning of treatment to conversion to MS according to McDonald 2005 criteria (Polman et al 2005)
Measure: Delay until conversion to MS
Time: 24 months
Other Outcomes
Measure: DNA sample (blood sample) for biobank
Time: baseline
Measure: Hemogram
Time: baseline
Measure: Hemogram
Time: 3 months
Measure: Hemogram
Time: 6 months
Measure: Hemogram
Time: 12 months
Measure: Hemogram
Time: 18 months
Measure: Hemogram
Time: 24 months
Measure: Hemogram
Time: upon conversion to MS (maximum 24 months)
Measure: alanine amino transferase serum levels
Time: baseline
Measure: alanine amino transferase serum levels
Time: 3 months
Measure: alanine amino transferase serum levels
Time: 6 months
Measure: alanine amino transferase serum levels
Time: 12 months
Measure: alanine amino transferase serum levels
Time: 18 months
Measure: alanine amino transferase serum levels
Time: 24 months
Measure: alanine amino transferase serum levels
Time: upon conversion to MS (maximum 24 months)
Measure: aspartate aminotransferase serum levels
Time: baseline
Measure: aspartate aminotransferase serum levels
Time: 3 months
Measure: aspartate aminotransferase serum levels
Time: 6 months
Measure: aspartate aminotransferase serum levels
Time: 12 months
Measure: aspartate aminotransferase serum levels
Time: 18 months
Measure: aspartate aminotransferase serum levels
Time: 24 months
Measure: aspartate aminotransferase serum levels
Time: upon conversion to MS (maximum 24 months)
Measure: alkaline phosphatase serum levels
Time: baseline
Measure: alkaline phosphatase serum levels
Time: 3 months
Measure: alkaline phosphatase serum levels
Time: 6 months
Measure: alkaline phosphatase serum levels
Time: 12 months
Measure: alkaline phosphatase serum levels
Time: 18 months
Measure: alkaline phosphatase serum levels
Time: 24 months
Measure: alkaline phosphatase serum levels
Time: upon conversion to MS (maximum 24 months)
Measure: serum calcium levels
Time: baseline
Measure: serum calcium levels
Time: 3 months
Measure: serum calcium levels
Time: 6 months
Measure: serum calcium levels
Time: 12 months
Measure: serum calcium levels
Time: 18 months
Measure: serum calcium levels
Time: 24 months
Measure: serum calcium levels
Time: upon conversion to MS (maximum 24 months)
Measure: serum creatinine levels
Time: baseline
Measure: serum creatinine levels
Time: 3 months
Measure: serum creatinine levels
Time: 6 months
Measure: serum creatinine levels
Time: 12 months
Measure: serum creatinine levels
Time: 18 months
Measure: serum creatinine levels
Time: 24 months
Measure: serum creatinine levels
Time: upon conversion to MS (maximum 24 months)
Measure: serum albumin levels
Time: baseline
Measure: serum albumin levels
Time: 3 months
Measure: serum albumin levels
Time: 6 months
Measure: serum albumin levels
Time: 12 months
Measure: serum albumin levels
Time: 18 months
Measure: serum albumin levels
Time: 24 months
Measure: serum albumin levels
Time: upon conversion to MS (maximum 24 months)
Measure: serum urea levels
Time: baseline
Measure: serum urea levels
Time: 3 months
Measure: serum urea levels
Time: 6 months
Measure: serum urea levels
Time: 12 months
Measure: serum urea levels
Time: 18 months
Measure: serum urea levels
Time: 24 months
Measure: serum urea levels
Time: upon conversion to MS (maximum 24 months)
Measure: serum bilirubin levels
Time: baseline
Measure: serum bilirubin levels
Time: 3 months
Measure: serum bilirubin levels
Time: 6 months
Measure: serum bilirubin levels
Time: 12 months
Measure: serum bilirubin levels
Time: 18 months
Measure: serum bilirubin levels
Time: 24 months
Measure: serum bilirubin levels
Time: upon conversion to MS (maximum 24 months)
Measure: serum electrolyte panel
Time: baseline
Measure: serum electrolyte panel
Time: 3 months
Measure: serum electrolyte panel
Time: 6 months
Measure: serum electrolyte panel
Time: 12 months
Measure: serum electrolyte panel
Time: 18 months
Measure: serum electrolyte panel
Time: 24 months
Measure: serum electrolyte panel
Time: upon conversion to MS (maximum 24 months)
Purpose: Prevention
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 T13D
Normalized cerebral volume (SIENAX) obtained from a T13D sequence. --- T13D ---
HPO Nodes