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Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health

1. marts 2019 opdateret af: Johns Hopkins University

Pharmacodynamic and Immunologic Effects of Vitamin D Supplementation in Patients With Multiple Sclerosis and Healthy Controls

This is a pilot study of oral vitamin D supplementation to determine if patients with Multiple Sclerosis (MS) and healthy individuals attain a similar increase in serum 25-hydroxyvitamin D levels. The investigators will also assess whether the immunologic or relevant gene expression response to oral vitamin D supplementation differs in patients with MS and healthy controls.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

57

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94143
        • University of California, San Francisco
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Female
  • Healthy or multiple sclerosis
  • Aged 18 to 60
  • Body mass index is between 18 kg/m2 and 30 kg/m2
  • Screening 25-hydroxyvitamin D level ≤ 75 nmol/L (30 ng/mL)
  • White race
  • Non-Hispanic ethnicity
  • Willing to use birth control during study
  • Willing to not use tanning bed during study

If subject has multiple sclerosis:

  • Relapsing-remitting MS, as defined by McDonald 2005 criteria
  • Screening Expanded Disability Status Scale score ≤ 3.0
  • Using no medication for MS, or taking Copaxone, (glatiramer acetate), interferons, or natalizumab

Exclusion Criteria:

  • Pregnant or nursing
  • Taking multivitamin & unwilling to remain off it during study
  • Taking cod liver oil & unwilling to remain off it during study
  • On a fat-restricted diet
  • History of renal disease or nephrolithiasis (kidney stones)
  • History of liver disease
  • Taking thiazide diuretics
  • History of hyperthyroidism
  • History of infection with Mycobacterium species
  • History of sarcoidosis
  • History of cancer
  • History of cardiac disease
  • History of HIV
  • History of gastrointestinal disorder
  • Taking medications that interfere with gastrointestinal absorption
  • Cigarette smoker in past month
  • Use of illicit drugs in past month
  • Use of steroids in past month
  • History of hypercalcemia, and screening serum calcium ≤ 10 mg/dL (UCSF) or ≤ 10.7 mg/dL (Johns Hopkins)
  • History of hypercalciuria
  • Evidence of anemia (Hgb <11.0 g/dL)
  • History of other serious medical conditions
  • Taking medications that involve the P450 system or may interact with vitamin D (digoxin, diltiazem, verapamil, cimetidine, heparin, or low-molecular weight heparin)
  • Other concerns about safety from the perspective of the treating physician

If subject has MS:

-History of major heat sensitivity (leading to sun-avoidant behaviors)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Vitamin D3
Both those with MS and healthy controls will be given vitamin D3 5000 IU/day by mouth for 90 days.
Kosttilskud: Vitamin D3

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Mean Serum Level of 25-hydroxyvitamin D
Tidsramme: Baseline to 90 days
Generalized estimating equations (GEE) with an autoregressive with lag one correlation matrix were used to compare the serially-measured serum 25(OH)D levels between MS patients and Healthy Controls (HCs) to take into account repeated measures and within-subject correlations.
Baseline to 90 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+)
Tidsramme: Baseline, 90 days
Analyzed the mean percentage change in IFNγ+ and IL-17+ cluster of differentiation 4 (CD4) + cells (post- versus pre- supplementation). This represents a change between two time points (90 days versus baseline).
Baseline, 90 days
Gene Expression Microarray
Tidsramme: 90 days
We had initially planned to do whole blood gene expression. The experience gained by the laboratory that was to perform this since the original trial was planned was that this measure is too noisy and would not yield meaningful results. Thus, this analysis will no longer be conducted.
90 days
Change in Cytokine Levels
Tidsramme: 90 days
The original plan had been to measure the change in basic serum cytokine levels (e.g. IL-17, interferon gamma; IL-10; pg/microliter). However, due to emerging data suggesting low utility of these measures, this plan was abandoned.
90 days
Change in Percentage of B Cells
Tidsramme: 90 days
The change in percentage (day 90-baseline) was originally planned for study. Due to the limited number of patients with samples this plan was abandoned.
90 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Johns Hopkins University

Samarbejdspartnere

University of California, San Francisco
National Multiple Sclerosis Society

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2010

Primær færdiggørelse (Faktiske)

1. marts 2014

Studieafslutning (Faktiske)

1. marts 2014

Datoer for studieregistrering

Først indsendt

13. august 2012

Først indsendt, der opfyldte QC-kriterier

14. august 2012

Først opslået (Skøn)

17. august 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NA_00049428
  • FG-1507-05231 (Andet bevillings-/finansieringsnummer: National Multiple Sclerosis Society)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Multipel sklerose, recidiverende-remitterende

Kliniske forsøg med Vitamin D3

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in South Korea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner