- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01388855
Pilot Study of Vitamin D Supplementation in Heart Failure
A Randomized, Double-Blind, Placebo-Controlled Trial of Vitamin D in Heart Failure: A Pilot Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is being conducted as a pilot project to determine the feasibility of the methods to inform the conduct of a future larger study. This double-blind randomized controlled trial will examine the relationship between vitamin D status, Quality of Life (QOL), pain and functional capacity of individuals living with heart failure (HF) pre and post vitamin D supplementation. The study outcome measures include: the rate of recruitment, retention and compliance with the study procedures. Quality of life will be measured by the EQ-5D™ questionnaire; the Brief Pain Inventory (BPI) will be used to evaluate subject pain. The 6-minute walk test (6MWT) will evaluate functional capacity. Serum 25-hydroxyvitamin D (25OHD) levels will quantify the adequacy of vitamin D dosing to achieve target 25OHD levels.
A convenience sample of 40 subjects (20 per treatment group) will be prospectively recruited from the Royal Columbian Hospital (RCH) Heart Function (HFx) Clinic. Subjects will be randomized to receive either vitamin D3 (cholecalciferol) or a matching placebo at a dose of 20,000 IU daily for 30 days followed by 20,000 IU once weekly for 8 weeks. Subjects will have their 25OHD levels measured, self-administer the EQ-5D™ and BPI questionnaires and perform the 6MWT at the study entry and again at the completion of the study (12 weeks after entry).
Descriptive statistics (mean, standard deviation and proportion as appropriate) will be used to describe the data. The feasibility of all study procedures will be reported by percentage and compared to the standard set by the team of 80%.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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British Columbia
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New Westminster, British Columbia, Canada, V3L 3W7
- Royal Columbian Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 65 years of age or older
- New York Heart Association functional Class II or III symptoms
- Ability to communicate in English or through a translator
- Competent to sign the informed consent
Exclusion Criteria:
- Co-morbidity that would negatively impact quality of life (e.g. severe arthritis, or fibromyalgia)
- Co-morbidity that would negatively impact vitamin D metabolism (glomerular filtration rate-15-29%, significant liver dysfunction
- On a pharmaceutical agent that could lower Vitamin D levels (e.g. glucocorticoids, anticonvulsants)
- Taking >600 IU vitamin D (cholecalciferol or ergocalciferol) daily
- Moderate or severe cognitive impairment
- Contraindication to vitamin D supplementation: history of hypercalcemia or conditions that increase the risk of hypercalcemia (sarcoidosis, tuberculosis or lymphoma)
- Wheelchair bound (ambulation is a component of the QOL questionnaire
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Cholecalciferol
Patients were given two cholecalciferol tablets (10,000 IU each) daily for 30 days.
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Subjects receive cholecalciferol 20,000 IU daily for 30 days followed by 20,000 IU once weekly for 8 weeks.
Andre navne:
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Placebo komparator: Placebo
Patients were given two cholecalciferol placebo tablets daily for 30 days.
|
Pills made to look like vitamin D but have no medication in them
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Rate of participant recruitment
Tidsramme: 6 months
|
The percentage of patients recruited from those that present to clinic.
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6 months
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Participant compliance with study procedures
Tidsramme: 6 months
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Proportion completing the quality of life questionnaire, 6 minute walk test and medication regimen
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6 months
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Participant rate of retention
Tidsramme: 6 months
|
Proportion of participants retained in study
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6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of participants with hypercalcemia as a measure of safety and tolerability.
Tidsramme: 6 months
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6 months
|
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Number of participants that achieve a target serum 25-hydroxyvitamin D of 75nmol/L
Tidsramme: 8 months
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8 months
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The values achieved for quality of life and pain questionnaire and functional capacity measure.
Tidsramme: 8 months
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Quality of life will be measured by the EQ-5D questionnaire.
Pain will be measured by the Brief Pain Inventory questionnaire.
Functional capacity will be measured by the standardized and validated 6 minute walk test.
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8 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Liz C da Silva, MS, Fraser Health Authority
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2011-028
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