- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01179503
Vitamin D Supplementation and Physical Function in Older Adults
15. august 2018 oppdatert av: Wake Forest University Health Sciences
Vitamin D Supplementation, Skeletal Muscle Gene Expression, and Physical Performance in Older Adults
A growing body of evidence suggests that vitamin D status is important in biologic processes involved in the maintenance of physical function.
To advance the investigators understanding of the role of vitamin D in physical function, the investigators will conduct a feasibility pilot study to collect key information to help design a full-scale randomized trial to determine whether vitamin D supplementation will delay declines in physical function.
The primary goals of the pilot study are to determine cost-effective strategies for identifying persons at high risk for functional decline with insufficient vitamin D levels, determine the serum vitamin D response to a vitamin D supplementation regimen designed to attain sufficient vitamin D levels, and provide preliminary data of key functional measures (balance, physical performance and muscle power) for the future larger study design.
A secondary goal is to begin to examine potential mechanisms by which vitamin D supplementation may enhance physical performance by exploring the effects of vitamin D supplementation on changes in skeletal muscle gene expression.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
A growing body of evidence suggests that vitamin D status is important in biologic processes involved in the maintenance of physical function.
However, whether remediation of vitamin D insufficiency will improve physical function and the potential mechanisms involved are unclear.
Previous vitamin D supplementation trials have produced mixed results with respect to physical function; however, most trials did not specifically recruit individuals who were vitamin D insufficient nor is the potential mechanism of action understood well enough to appropriately select those individuals most likely to benefit.
To advance our understanding of the role of vitamin D in physical function, the investigators will conduct a feasibility pilot study to collect key information to help design a full-scale randomized trial to determine whether vitamin D supplementation will delay declines in physical function.
The primary goals of the pilot study are to determine cost-effective strategies for identifying persons at high risk for functional decline with insufficient vitamin D levels, determine the serum vitamin D response to a vitamin D supplementation regimen designed to attain sufficient vitamin D levels, and provide preliminary data of key functional measures (balance, short physical performance battery (SBBP) and muscle power) for the future larger study design.
A secondary goal is to begin to examine potential mechanisms by which vitamin D supplementation may enhance physical performance and muscle contractility by exploring the effects of vitamin D supplementation on changes in skeletal muscle gene expression using microarrays.
Studietype
Intervensjonell
Registrering (Faktiske)
16
Fase
- Tidlig fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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North Carolina
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Winston-Salem, North Carolina, Forente stater, 27157
- Wake Forest University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
70 år til 89 år (Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Short Physical Performance Battery (SPPB) score of ≥ 4 to < 10
- Vitamin D insufficient (serum 25(OH)D ≥ 10 to < 25 ng/mL)
Exclusion Criteria:
- Serious or uncontrolled chronic disease including: insulin-dependent or uncontrolled diabetes; cancer requiring treatment in past year, except non-melanoma skin cancers; past or current ischemic heart disease, uncontrolled angina, heart failure, peripheral artery disease (PAD), or stroke; chronic respiratory disease; uncontrolled endocrine/metabolic disease; neurological or hematological disease; liver or renal dysfunction; and severe musculoskeletal impairment
- Impaired cognitive function (MMSE ≤ 24)
- Dependent on a cane or walker
- Use of anti-coagulants
- Unwillingness to undergo a muscle biopsy
- Taking prescription vitamin D2 or OCT vitamin D3 supplements of > 1000 IU/d
- Inability or contraindications to consume daily vitamin D and calcium supplements
- Weight loss of ≥ 5% or more in the past 6 months
- Involved in any other intervention
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Calcium only
1200 mg Calcium per day
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600 mg calcium carbonate twice daily (total of 1200 mg/day) for 4 months
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Eksperimentell: Vitamin D plus calcium
2000 IU vitamin D plus 1200 mg calcium per day
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1000 IU of vitamin D3 twice daily (for a total of 2000 IU/day) plus 600 mg calcium carbonate twice daily (for a total of 1200 mg/day)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Physical performance
Tidsramme: 4 months
|
Change in the expanded Short Physical Performance Battery (SPPB) score (composite score including the following: timed 4m walk; time to stand from a chair 5 times without the use of arms; and time to hold side-by-side, semi-tandem, tandem, and one legged stands for the testing of balance)
|
4 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Skeletal muscle gene expression
Tidsramme: 4 months
|
Muscle will be obtained from the vastus lateralis using the percutaneous needle biopsy technique.
Five µg of RNA will be supplied for each experimental condition to be analyzed.
The WFUHS MicroArray Core Facility further purifies the provided RNA over an RNAeasy column and performs all subsequent steps of the GeneChip protocol (cDNA generation, generation of biotinylated cRNA, chip hybridization, and generation of .CEL files).
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4 months
|
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Change in expanded SPPB balance task time
Tidsramme: 4 months
|
Change in expanded SPPB balance task time (time to hold side-by-side, semi-tandem, tandem, and one legged stands; max of 30 sec)
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4 months
|
|
Change in narrow 4m walk test of balance time
Tidsramme: 4 months
|
Change in time to complete narrow 4m walk test of balance (usual pace over 4m while staying between lines of colored tape placed 20cm apart)
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4 months
|
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Change in 400m walk test time
Tidsramme: 4 months
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Change in 400m walk test time (usual pace)
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4 months
|
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Change in knee extensor power
Tidsramme: 4 months
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Change in knee extensor power measured by the Nottingham Power Rig
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4 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Studieleder: Denise K Houston, PhD, Wake Forest University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2010
Primær fullføring (Faktiske)
1. mai 2011
Studiet fullført (Faktiske)
1. mai 2011
Datoer for studieregistrering
Først innsendt
10. august 2010
Først innsendt som oppfylte QC-kriteriene
10. august 2010
Først lagt ut (Anslag)
11. august 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. august 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. august 2018
Sist bekreftet
1. august 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00011371
- R01AG029364-03S1 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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