- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01410084
Improving Vitamin D Status in Home-bound Elders (MOW VitD)
Improving Vitamin D Status in Home-bound Elders: a Pilot Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
In the past two decades, the role of vitamin D has extended beyond bone health to encompass a wide range of biological activities important to physical function in older adults. A growing body of evidence now shows that circulating 25-hydroxyvitamin D (25(OH)D) levels < 75 nmol/L (< 30 ng/mL)) are associated with physical impairments such as reduced walking speed and impaired balance as well as falls. Older adults are at risk for low levels of 25-hydroxyvitamin D because of reduced exposure to ultraviolet B radiation, reduced efficiency of previtamin D synthesis in the skin, and low dietary intake. Although data from the National Health and Nutrition Examination Survey (NHANES) 2000-2004 indicate that frank vitamin D deficiency (serum 25(OH)D < 25 nmol/L [10 ng/mL]) is rare in the U.S. (5% or less), vitamin D insufficiency (serum 25(OH)D < 75 nmol/L [30 ng/mL]) is prevalent (~75%) among older adults. Older home-bound adults are a vulnerable subgroup of older adults for poor dietary intake and nutritional health, nutrition-related health conditions, and functional decline and disability. The primary goal of this pilot study is to assess the feasibility of a partnership with Senior Services of Forsyth County to address vitamin D insufficiency in home-bound older adults receiving home-delivered meals. The investigators will accomplish this goal by conducting a 5-month randomized, controlled trial in 200 older Meals-on-Wheels (MOW) recipients randomized to receive monthly either (1) 100,000 IU vitamin D3 or (2) an active placebo (vitamin E) to achieve the following specific aims:
Aim 1: Determine the prevalence of falls and risk of vitamin D insufficiency in 200 MOW recipients.
Aim 2: Assess the feasibility of the vitamin D intervention delivered through the MOW program.
Aim 3: Obtain preliminary data on the effectiveness of the intervention on improving vitamin D status and reducing falls.
Data from this pilot study will: 1) provide estimates of the prevalence of falls and vitamin D insufficiency in home-bound older adults participating in the Forsyth County MOW program; 2) provide estimates of participant compliance and drop-out to a vitamin supplementation trial delivered as part of the MOW program; 3) provide evidence for the efficacy of the vitamin D dose proposed in remediating vitamin D insufficiency; and 4) provide preliminary data on the potential benefit of vitamin D supplementation on falls in a home-bound older population.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
North Carolina
-
Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age ≥ 65 years old
- Forsyth County Senior Services Meals-on-Wheels recipient
- Willing to provide informed consent
- Willing to be randomized to vitamin D or active placebo control
Exclusion Criteria:
- Hyperparathyroidism
- Kidney stones (within the past 2 years)
- History of hypercalcemia
- On dialysis
- Inability or contraindications to consume vitamin D supplements
- Taking prescription vitamin D2 or vitamin D3-containing supplements totaling > 1000 IU/d
- Planning to move within the next 6 months
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Vitamin D3
100,000 IU vitamin D3 once monthly
|
100,000 IU vitamin D3 once monthly for 5 months
|
|
Placebo komparator: Vitamin E
400 IU vitamin E once monthly
|
400 IU vitamin E once monthly for 5 months
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in 25-hydroxyvitamin D Levels Over 5 Months
Tidsramme: 5 months
|
Determine the effectiveness of the intervention on improving 25-hydroxyvitamin D levels (change in 25(OH)D from baseline to 5-month follow-up).
Measured as 5-month follow-up 25(OH)D level minus baseline 25(OH)D level.
|
5 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Falls
Tidsramme: 5 months
|
Determine the effectiveness of the intervention on reducing the number of falls using monthly fall calendars (compare the average number of falls in vitamin D3 group vs. active placebo group over 5 months)
|
5 months
|
|
Number of Participants Who Were Compliant to Intervention
Tidsramme: 5 months
|
Number of participants who consumed at least 4 out of a possible 5 supplement doses (=>80% compliance) over 5 months.
|
5 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Denise K Houston, PhD, Wake Forest University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
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 (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Ernæringsforstyrrelser
- Avitaminose
- Mangelsygdomme
- Fejlernæring
- D-vitamin mangel
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Beskyttelsesagenter
- Mikronæringsstoffer
- Knogletæthedsbevarende midler
- Calciumregulerende hormoner og midler
- Antioxidanter
- D-vitamin
- Cholecalciferol
- E-vitamin
- Vitaminer
Andre undersøgelses-id-numre
- IRB00014152
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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