- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01410084
Improving Vitamin D Status in Home-bound Elders (MOW VitD)
Improving Vitamin D Status in Home-bound Elders: a Pilot Study
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Winston-Salem, North Carolina, 미국, 27157
- Wake Forest University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Vitamin D3
100,000 IU vitamin D3 once monthly
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100,000 IU vitamin D3 once monthly for 5 months
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위약 비교기: Vitamin E
400 IU vitamin E once monthly
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400 IU vitamin E once monthly for 5 months
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in 25-hydroxyvitamin D Levels Over 5 Months
기간: 5 months
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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.
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5 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Falls
기간: 5 months
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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)
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5 months
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Number of Participants Who Were Compliant to Intervention
기간: 5 months
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Number of participants who consumed at least 4 out of a possible 5 supplement doses (=>80% compliance) over 5 months.
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5 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Denise K Houston, PhD, Wake Forest University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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