SNPMiner Trials by Shray Alag

NCT00511368 (37) NCT00460382 (36) NCT04504071 (35) NCT03783286 (33) NCT04172597 (32) NCT02404233 (29) NCT00959894 (28) NCT00706147 (28) NCT00121017 (28) NCT01685801 (27) NCT04513626 (26) NCT01736761 (26) NCT04495348 (24) NCT02673398 (23) NCT02499978 (22) NCT01605084 (21) NCT04254705 (21) NCT02069834 (21) NCT00939770 (18) NCT01792570 (18) NCT01199939 (18) NCT00356616 (18) NCT02728258 (17) NCT02707601 (17) NCT02770508 (16) NCT00711009 (16) NCT00630864 (16) NCT00491556 (15) NCT04085315 (15) NCT02616029 (15) NCT00830804 (15) NCT01170962 (14) NCT00984152 (14) NCT03953898 (14) NCT00727597 (14) NCT03212274 (14) NCT00337467 (13) NCT00098293 (13) NCT02159599 (13) NCT00424814 (12) NCT04432454 (12) NCT02527096 (12) NCT01849003 (12) NCT03781063 (12) NCT03683524 (11) NCT01614457 (11) NCT00460746 (11) NCT00993148 (11) NCT03061331 (11) NCT02494882 (11) NCT03068312 (11) NCT04453436 (11) NCT01521338 (10) NCT01614470 (10) NCT01423812 (10) NCT00358917 (10) NCT04415268 (10) NCT00511381 (10) NCT03911713 (9) NCT02742519 (9) NCT02725567 (9) NCT03045523 (9) NCT00438152 (9) NCT01102972 (9) NCT02971839 (9) NCT00740064 (9) NCT02605954 (9) NCT00379405 (9) NCT01562847 (9) NCT02616783 (9) NCT04272242 (9) NCT02445053 (9) NCT00242840 (9) NCT02724527 (9) NCT04209465 (9) NCT04585737 (8) NCT02082977 (8) NCT00112775 (8) NCT00383318 (8) NCT03659214 (8) NCT03631732 (8) NCT00118898 (8) NCT01888562 (8) NCT02633189 (8) NCT03565692 (8) NCT03843775 (8) NCT01161576 (8) NCT02167165 (8) NCT00344461 (8) NCT04519398 (7) NCT02154490 (7) NCT03232892 (7) NCT00650832 (7) NCT04549025 (7) NCT00440947 (7) NCT02784639 (7) NCT03572140 (6) NCT01237444 (6) NCT00532168 (6) NCT01102569 (6) NCT04424368 (6) NCT01414985 (6) NCT00525733 (6) NCT02308332 (6) NCT01487265 (6) NCT00049933 (5) NCT02389920 (5) NCT03351699 (5) NCT04197934 (5) NCT02272998 (5) NCT00122590 (5) NCT04204330 (5) NCT02450591 (5) NCT01173029 (5) NCT02675829 (5) NCT02858921 (5) NCT01914484 (5) NCT00187733 (5) NCT02554591 (5) NCT01501604 (5) NCT02716116 (5) NCT01136460 (5) NCT00187655 (5) NCT00350272 (5) NCT00837135 (5) NCT03202862 (5) NCT01707199 (5) NCT03839342 (5) NCT01323010 (4) NCT02248324 (4) NCT01698905 (4) NCT01737359 (4) NCT01306045 (4) NCT02804100 (4) NCT01456676 (4) NCT00588172 (4) NCT03434418 (4) NCT03593993 (4) NCT01804140 (4) NCT02882308 (4) NCT03497767 (4) NCT04106024 (4) NCT02716311 (4) NCT04405674 (4) NCT03599518 (4) NCT01675778 (4) NCT01604122 (4) NCT01297777 (4) NCT04519970 (4) NCT00705679 (4) NCT04147351 (4) NCT04129502 (4) NCT03976856 (4) NCT02335944 (4) NCT03948763 (4) NCT03255083 (4) NCT04002830 (4) NCT02635815 (4) NCT03066206 (4) NCT01331642 (4) NCT00557245 (4) NCT01922583 (4) NCT02893332 (4) NCT03592888 (4) NCT02257424 (4) NCT03874858 (4) NCT00017732 (4) NCT00187720 (4) NCT02593539 (4) NCT01185587 (4) NCT04439292 (4) NCT03884348 (4) NCT01309243 (4) NCT03209063 (4) NCT04160546 (4) NCT03292302 (4) NCT02418234 (4) NCT02535338 (3) NCT02192697 (3) NCT03410043 (3) NCT03845296 (3) NCT02914990 (3) NCT02113813 (3) NCT01532011 (3) NCT04340388 (3) NCT00962533 (3) NCT03856411 (3) NCT04049266 (3) NCT02973763 (3) NCT02926092 (3) NCT00271973 (3) NCT04256941 (3) NCT03812809 (3) NCT02954523 (3) NCT01784068 (3) NCT03446417 (3) NCT02841579 (3) NCT02025114 (3) NCT01288521 (3) NCT01385683 (3) NCT02279004 (3) NCT00998582 (3) NCT03111901 (3) NCT01352715 (3) NCT01619774 (3) NCT01045369 (3) NCT02246998 (3) NCT03969823 (3) NCT00895596 (3) NCT02398929 (3) NCT00724711 (3) NCT04029350 (3) NCT03737994 (3) NCT01443806 (3) NCT02629822 (3) NCT03463525 (3) NCT00710112 (3) NCT03623750 (3) NCT04283955 (3) NCT02743923 (3) NCT01016106 (3) NCT01259089 (3) NCT03971474 (3) NCT02917993 (3) NCT02368990 (3) NCT00279110 (3) NCT02485652 (3) NCT00312169 (3) NCT04541407 (3) NCT02769286 (3) NCT00747487 (3) NCT04267913 (3) NCT01429597 (3) NCT04023617 (3) NCT03790228 (3) NCT01759888 (3) NCT04429152 (3) NCT01810718 (3) NCT02725632 (3) NCT01090011 (3) NCT04544111 (3) NCT02926768 (3) NCT02981108 (3) NCT02459743 (3) NCT00654823 (3) NCT01037127 (3) NCT04439305 (3) NCT01028222 (3) NCT01542411 (3) NCT01031446 (3) NCT02726269 (3) NCT01892644 (3) NCT03260491 (3) NCT01802632 (3) NCT02720094 (3) NCT02630186 (3) NCT01627132 (3) NCT02690675 (3) NCT01013506 (3) NCT04252339 (3) NCT02496663 (3) NCT03386955 (3) NCT03394118 (3) NCT04212702 (3) NCT01754025 (3) NCT01160276 (3) NCT00121979 (3) NCT03228277 (3) NCT04351555 (3) NCT01243346 (3) NCT04510415 (3) NCT02796274 (3) NCT02774005 (3) NCT02064491 (3) NCT04233021 (3) NCT03799601 (3) NCT00260260 (3) NCT02094261 (3) NCT04245085 (3) NCT01282151 (3) NCT03058094 (3) NCT02520778 (3) NCT03161808 (3) NCT04181060 (3) NCT01342679 (3) NCT01443273 (3) NCT01593254 (3) NCT04433481 (3) NCT02529995 (3) NCT03502850 (3) NCT02771314 (3) NCT03823807 (3) NCT03270527 (3) NCT02688881 (3) NCT01005602 (3) NCT02442349 (3) NCT02282267 (2) NCT02684591 (2) NCT03381430 (2) NCT02178397 (2) NCT03608215 (2) NCT02603107 (2) NCT03370770 (2) NCT03322696 (2) NCT00525473 (2) NCT03333343 (2) NCT03127449 (2) NCT01781026 (2) NCT02503722 (2) NCT00975871 (2) NCT03964233 (2) NCT03388099 (2) NCT02317016 (2) NCT03845270 (2) NCT03519958 (2) NCT03918304 (2) NCT02151721 (2) NCT02777658 (2) NCT01016444 (2) NCT02971501 (2) NCT03101254 (2) NCT03178617 (2) NCT01774721 (2) NCT03574753 (2) NCT01357655 (2) NCT01766713 (2) NCT02097225 (2) NCT00658164 (2) NCT03622593 (2) NCT02571036 (2) NCT00834665 (2) NCT00969137 (2) NCT02026011 (2) NCT03622580 (2) NCT03543683 (2) NCT01143493 (2) NCT03671538 (2) NCT04028778 (2) NCT00324961 (2) NCT01915576 (2) NCT02157883 (2) NCT01387022 (2) NCT03864042 (2) NCT03235245 (2) NCT03469960 (2) NCT02795884 (2) NCT00005541 (2) NCT01242813 (2) NCT02906020 (2) NCT03960645 (2) NCT00643058 (2) NCT03443336 (2) NCT02992860 (2) NCT02281760 (2) NCT02201602 (2) NCT04310007 (2) NCT03720665 (2) NCT04309019 (2) NCT00909532 (2) NCT00411944 (2) NCT01604681 (2) NCT01245062 (2) NCT00270231 (2) NCT03256136 (2) NCT03973918 (2) NCT00302692 (2) NCT00125281 (2) NCT02163733 (2) NCT02110407 (2) NCT00475176 (2) NCT03196882 (2) NCT01572818 (2) NCT02556333 (2) NCT04268550 (2) NCT02433717 (2) NCT03428126 (2) NCT01153763 (2) NCT02609776 (2) NCT01420211 (2) NCT03556176 (2) NCT03872440 (2) NCT01405079 (2) NCT03382795 (2) NCT02991950 (2) NCT00013598 (2) NCT03455764 (2) NCT02422628 (2) NCT03831932 (2) NCT03766490 (2) NCT02580474 (2) NCT00499577 (2) NCT02444884 (2) NCT01775943 (2) NCT03544814 (2) NCT01310036 (2) NCT01027663 (2) NCT01928160 (2) NCT01244438 (2) NCT00007150 (2) NCT04462081 (2) NCT02297425 (2) NCT02086071 (2) NCT01050400 (2) NCT03060590 (2) NCT01819428 (2) NCT02709668 (2) NCT02411448 (2) NCT03878719 (2) NCT04479306 (2) NCT03377023 (2) NCT01378026 (2) NCT00226551 (2) NCT03239145 (2) NCT04511533 (2) NCT02191891 (2) NCT04586270 (2) NCT04545710 (2) NCT02120222 (2) NCT02738593 (2) NCT00831272 (2) NCT04469543 (2) NCT00573495 (2) NCT04158544 (2) NCT00904150 (2) NCT02110056 (2) NCT02856893 (2) NCT02110043 (2) NCT02182986 (2) NCT04179890 (2) NCT00063232 (2) NCT02197234 (2) NCT03121235 (2) NCT01532089 (2) NCT03887169 (2) NCT02268864 (2) NCT01963845 (2) NCT00866736 (2) NCT03977194 (2) NCT03991013 (2) NCT02500927 (2) NCT02228382 (2) NCT02689570 (2) NCT01513785 (2) NCT02463435 (2) NCT03351361 (2) NCT04527549 (2) NCT03424759 (2) NCT02197247 (2) NCT02321046 (2) NCT04272034 (2) NCT04027647 (2) NCT02364609 (2) NCT02759835 (2) NCT04349865 (2) NCT00068159 (2) NCT00418015 (2) NCT04310397 (2) NCT03088176 (2) NCT03867175 (2) NCT00339209 (2) NCT00011258 (2) NCT01288430 (2) NCT01616199 (2) NCT03603262 (2) NCT03071705 (2) NCT00969930 (2) NCT00772408 (2) NCT02743468 (2) NCT00277342 (2) NCT04248829 (2) NCT01767454 (2) NCT00933127 (2) NCT03317873 (2) NCT03392246 (2) NCT01909453 (2) NCT03523104 (2) NCT00085917 (2) NCT02507921 (2) NCT03781752 (2) NCT03828422 (2) NCT02193282 (2) NCT03195452 (2) NCT02294487 (2) NCT01325441 (2) NCT02511106 (2) NCT02997501 (2) NCT04184921 (2) NCT00625092 (2) NCT01657786 (2) NCT01415011 (2) NCT02629523 (2) NCT01718847 (2) NCT02818023 (2) NCT00577707 (2) NCT01943422 (2) NCT00116636 (2) NCT01841463 (2) NCT04429542 (2) NCT03865511 (2) NCT01218477 (2) NCT03205267 (2) NCT02881320 (2) NCT01897480 (2) NCT02810990 (2) NCT04189757 (2) NCT01951001 (2) NCT04254939 (2) NCT03207867 (2) NCT00780949 (2) NCT03355768 (2) NCT00817089 (2) NCT02143466 (2) NCT04499053 (2) NCT01907776 (2) NCT00909727 (2) NCT01562028 (2) NCT03737253 (2) NCT00441974 (2) NCT02155465 (2) NCT04586335 (2) NCT00661999 (2) NCT02705339 (2) NCT04006340 (2) NCT04553887 (2) NCT03852290 (2) NCT02183922 (2) NCT03970239 (2) NCT00294372 (2) NCT03250676 (2) NCT03792074 (2) NCT00671892 (2) NCT00689182 (2) NCT00106379 (2) NCT01947023 (2) NCT00509652 (2) NCT03683251 (2) NCT02039986 (2) NCT03515837 (2) NCT04081688 (2) NCT03190005 (2) NCT01584648 (2) NCT02292654 (2) NCT03992456 (2) NCT03133546 (2) NCT01485809 (2) NCT01266967 (2) NCT02909712 (2) NCT00062764 (2) NCT01776684 (2) NCT03042221 (2) NCT01940809 (2) NCT01161537 (2) NCT01154816 (2) NCT01175759 (2) NCT01199731 (2) NCT02788058 (2) NCT03130452 (2) NCT01772732 (2) NCT02631447 (2) NCT02525692 (2) NCT02526537 (2) NCT03513666 (2) NCT02027961 (2) NCT03106779 (2) NCT04106544 (2) NCT04258943 (2) NCT00165984 (2) NCT00977470 (2) NCT02092974 (2) NCT03975231 (2) NCT01998295 (2) NCT03586453 (2) NCT02021305 (2) NCT03135197 (2) NCT00432016 (2) NCT03004625 (2) NCT03851445 (2) NCT04031898 (2) NCT04201418 (2) NCT01911507 (2) NCT03539224 (2) NCT01978236 (2) NCT00866177 (2) NCT00320879 (2) NCT00044304 (2) NCT01999179 (2) NCT00977730 (2) NCT02491775 (2) NCT00212147 (2) NCT02040064 (2) NCT00489385 (2) NCT01713023 (2) NCT04122729 (2) NCT03994393 (2) NCT02438722 (2) NCT02762448 (2) NCT00071903 (2) NCT00626223 (2) NCT01193829 (2) NCT03239340 (2) NCT02991274 (2) NCT02811354 (2) NCT03416530 (2) NCT02522988 (2) NCT00953706 (2) NCT02346955 (2) NCT03795688 (2) NCT02011945 (2) NCT00857675 (2) NCT00028262 (2) NCT02355431 (2) NCT02495233 (2) NCT04575415 (2) NCT03468985 (2) NCT00230087 (2) NCT02017600 (2) NCT04146298 (2) 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NCT01647711 (1) NCT03231722 (1) NCT03576937 (1) NCT04412070 (1) NCT00554866 (1) NCT03151161 (1) NCT01817166 (1) NCT02220855 (1) NCT02512627 (1) NCT04591197 (1) NCT03402048 (1) NCT04500704 (1) NCT02323724 (1) NCT01166126 (1) NCT03029858 (1) NCT04317599 (1) NCT00300573 (1) NCT00809211 (1) NCT01393730 (1) NCT02318368 (1) NCT02228369 (1) NCT01074398 (1) NCT04500717 (1) NCT03134131 (1) NCT01004497 (1) NCT02455167 (1) NCT02073279 (1) NCT02117817 (1) NCT00323687 (1) NCT01605981 (1) NCT01371955 (1) NCT04147767 (1) NCT04144257 (1) NCT03490123 (1) NCT04423185 (1) NCT02625337 (1) NCT03567629 (1) NCT03360929 (1) NCT00109278 (1) NCT04108156 (1) NCT02132598 (1) NCT00542451 (1) NCT01587573 (1) NCT00868465 (1) NCT01494402 (1) NCT00867139 (1) NCT03363139 (1) NCT01936051 (1) NCT02341131 (1) NCT00037076 (1) NCT00582907 (1) NCT02169869 (1) NCT03284684 (1) NCT04204473 (1) NCT01074359 (1) NCT01400191 (1) NCT04530565 (1) NCT03530319 (1) NCT04146402 (1) NCT02658682 (1) NCT04241835 (1) NCT03133234 (1) 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SNPMiner SNPMiner Trials (Home Page)


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