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Improving Vitamin D Status in Home-bound Elders (MOW VitD)

31. juli 2019 opdateret af: Wake Forest University Health Sciences

Improving Vitamin D Status in Home-bound Elders: a Pilot Study

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. A secondary goal is to obtain preliminary data on the effectiveness of vitamin D supplementation on improving vitamin D levels and reducing falls.

Studieoversigt

Status

Afsluttet

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

Interventionel

Tilmelding (Faktiske)

68

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest 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

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

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

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

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

Efterforskere

  • Ledende efterforsker: Denise K Houston, PhD, Wake Forest University

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 (Faktiske)

1. oktober 2010

Primær færdiggørelse (Faktiske)

1. august 2011

Studieafslutning (Faktiske)

1. august 2011

Datoer for studieregistrering

Først indsendt

3. august 2011

Først indsendt, der opfyldte QC-kriterier

3. august 2011

Først opslået (Skøn)

4. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 D-vitamin mangel

Kliniske forsøg med Vitamin D3

Abonner