The Role of Vitamin D in Immune Function in Patients With Chronic Kidney Disease (CKD) Stages 3 and 4.
The Role of Vitamin D in Immune Function in Patients With CKD Stages 3 and 4.
Patients with chronic kidney disease (CKD) are commonly deficient in vitamin D, with low levels of both calcidiol (25 hydroxy vitamin D) and calcitriol (1,25-hydroxy vitamin D). Patients with CKD are also known to have abnormalities in their immune cells, increased susceptibility to infection and increased prevalence of malignancies. In patients without kidney disease, repletion of vitamin D appears to help some immune mediated diseases. Thus it is logical that patients with CKD who are vitamin D deficient may benefit from repletion of vitamin D, in either its native form (cholecalciferol/ergocalciferol) or in the form of calcitriol or its analogues. However, no interventional data demonstrates that repletion positively impacts immune status in CKD patients. To test this hypothesis, a large interventional study will be required. However, prior to conducting this study, several important steps are needed. The present proposal aims to generate the necessary data to appropriately plan and conduct a future multi center interventional study. Specifically, we will examine the following specific aims in a population of CKD stage 3 and 4 subjects from Indiana University Affiliated Nephrology Clinics and determine
- if abnormalities in immune cells and immune blood tests are related to abnormalities in vitamin D.
- how reproducible these changes are on repeat testing and
- if repletion of vitamin D changes these cells and immune blood tests in a small pilot study.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- Indiana University School of Medicine
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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:
- no administration of any form of vitamin D supplement or therapy in the last 60 days except for that in a multi vitamin
- Hgb >10 mg/dl
- able to sign informed consent
- CKD stage 3 (GFR 30-59ml/min) or stage 4 (GFR 15-29ml/min)
- iPTH <70pg/ml for stage 3 or iPTH <110pg/ml for stage 4
- calcidiol levels < or +20ng/ml
Exclusion Criteria:
- initial corrected Calcium >9.7mg/dl
- initial serum Phosphorus >5.0mg/dl
- initial standardized blood pressure of >160/100
- history of significant liver disease or cirrhosis
- anticipated requirement for dialysis in 6 months
- malabsorption, severe chronic diarrhea, or ileostomy
- no calcimimetic or active vitamin D therapy 60 days prior to enrollment
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:基礎科学
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:1
4000 IU of cholecalciferol per day
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4000 IU of cholecalciferol per day 15 patients will be enrolled in each arm. |
アクティブコンパレータ:2
1 mcg of doxercalciferol per day.
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1 mcg of doxercalciferol per day
|
プラセボコンパレーター:3
placebo for six months
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placebo for 6 months; with stratification based on stage of CKD by modified MDRD formula. 15 patients will be enrolled in each arm. |
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 |
時間枠 |
---|---|
The primary endpoint will be the change in CD4+/CD8+ ratio and other flow cytometry parameters based on the results of Aims 1 and 2, TH1/TH2 cytokine profile, and conversion from anergic to reactive skin testing.
時間枠:6 months from baseline visit
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6 months from baseline visit
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
A change in mean blood pressure from one week of ambulatory measures, random protein/creatinine ratio, and differences in muscle strength by timed up and go test, and measures of quality of life using the SF36 forms.
時間枠:6 months from baseline visit.
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6 months from baseline visit.
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Sharon M Moe, MD、Indiana University School of Medicine
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 0707-04
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。
慢性腎臓病の臨床試験
-
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