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Report for Clinical Trial NCT01817166

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Multicentric, Randomized, Double-blind Versus Placebo Study Evaluating the Efficacy of Treatment With Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of Multiple Sclerosis (MS) After a Clinically Isolated Syndrome (CIS). Comparison of Conversion Rates After 2 Years.

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).

NCT01817166 Multiple Sclerosis
MeSH:Multiple Sclerosis Sclerosis

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
Group Labels: 1

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
Group Labels: 1

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
Group Labels: 2

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
Group Labels: 2

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
Group Labels: 2

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
Group Labels: 2

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