Improving Vitamin D Status in Home-bound Elders (MOW VitD)
Improving Vitamin D Status in Home-bound Elders: a Pilot Study
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27157
- Wake Forest University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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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プラセボコンパレーター: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in 25-hydroxyvitamin D Levels Over 5 Months
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Falls
時間枠: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
時間枠: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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協力者と研究者
捜査官
- 主任研究者:Denise K Houston, PhD、Wake Forest University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
ビタミンD欠乏症の臨床試験
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University of UlsterAgri-Food and Biosciences Institute; Foodovation North West Regional College; Kenedy Bacon; Sofina... と他の協力者招待による登録ビタミンDステータス | ビタミンDバイオフォーティフィケーション | ビタミンD強化イギリス
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University of UlsterDairy Council for Northern Ireland; Agri-food & Biosciences Institute; Center for Nutrition and...完了
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University of UlsterNorthern Ireland Executive; HSC Public Health Agency完了
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Universitaire Ziekenhuizen KU LeuvenKU Leuven募集
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The Jerzy Kukuczka Academy of Physical Education...募集ビタミンD欠乏症/不足 | ビタミンD 25-ヒドロキシラーゼ欠損症ポーランド
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University of Eastern Finland完了ビタミン D 受容体標的遺伝子の発現 | 血清25(OH)D濃度フィンランド
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University of Eastern FinlandDSM Nutritional Products, Inc.完了ビタミン D 受容体標的遺伝子の発現 | 血清25(OH)D濃度フィンランド
Vitamin D3の臨床試験
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Aalborg UniversityAalborg University Hospital; CCBR Aalborg A/S, Aalborg, Denmark完了
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Riphah International University募集足底疣贅 | いぼ | 一般的な疣贅 | いぼの手 | フラットイボ | ウイルスいぼ | 尋常性疣贅(尋常性疣贅) | 足のいぼパキスタン