Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease
Randomized Trial of Two Maintenance Doses of Vitamin D and Trace Element Status in Children With Chronic Kidney Disease
Vitamin D deficiency is common in the general population and more common in children with chronic kidney disease. Vitamin D is very important for bone health, especially in children with chronic kidney disease. To date, several studies using different doses of vitamin D have been tried to correct vitamin D deficiency, but none has been completely successful. The investigators are comparing two different doses of vitamin D to determine which one is more effective at correcting and maintaining normal blood levels of vitamin D. The investigators hypothesize that a higher percentage of children receiving a higher dose of vitamin D will be vitamin D replete at the end of 6 months.
This study will enroll 80 children 9 to 18 years old who have chronic kidney disease (CKD) and can take pills. They will be enrolled from Chronic Renal Insufficiency Clinic, the Hemodialysis Unit, Peritoneal Dialysis Clinic and Transplant Clinic at Children's Healthcare of Atlanta.
調査の概要
詳細な説明
Vitamin D has a critical role in bone metabolism. In addition, there is increasing evidence that vitamin D has an important role in many other areas, including cardiovascular health, immune function, and prevention of autoimmune diseases and certain malignancies. In patients with CKD, there are a variety of abnormalities in mineral metabolism that lead to bone disease.
After the investigators obtain informed consent and assent, children will be randomly assigned to either low dose (1000 units daily) or high dose (4000 units daily) vitamin D pills (50% in each group). Participants will take vitamin D capsules every day for for 6 months. Vitamin D levels will be obtained at baseline, 3 months and 6 months. The study visits will be at the same time as routine clinic visits when the children are having blood drawn for routine care. At the end of the study, the investigators will compare the percentage of patients who have normal vitamin D levels at 6 months in the two groups. The investigators will also describe the percentage of patients who have elevated or low levels of trace elements.
The two doses of vitamin D in this study are within the dosing range recommended by the Institute of Medicine, and thus the investigators do not anticipate any adverse effects. Vitamin D toxicity could theoretically occur, and an elevated vitamin D level at 3 months would be an indication to withdraw a patient from the study.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Georgia
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Atlanta、Georgia、アメリカ、30322
- Childen's Healthcare of Atlanta
-
-
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:
- Patient's parent/legal guardian must be willing and able to give written informed consent and the patient must be willing to give written informed assent if applicable
- Estimated glomerular filtration rate < 60 mL/min/1.73 m2 body surface area or recipient of a kidney transplant
- 9-21 years old
- Able to swallow pills
Exclusion Criteria:
- Liver failure
- Malabsorption
- Current calcium level >10.5 mg/dL
- History of hypercalcemia (Ca >11 mg/dL) during the preceding 6 months
- Current treatment with an antiepileptic drug or other medications that may affect vitamin D metabolism (e.g., phenobarbital, phenytoin, rifampicin)
- History of hypervitaminosis D
- Completion of a course of high dose vitamin D within the preceding 2 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：4倍
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：1000 IU of Vitamin D Daily
Participants randomized to take a 1000 IU capsule of Vitamin D every day for 6 months.
|
1000 IU of Vitamin D will be administered in capsule form, once daily.
|
|
実験的：4000 IU of Vitamin D Daily
Participants randomized to take a 4000 IU capsule of Vitamin D capsule every day for 6 months.
|
4000 IU of Vitamin D will be administered in capsule form, once daily.
|
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 |
|---|---|---|
|
Percentage of Participants with Adequate Vitamin D Level
時間枠：Month 6
|
Vitamin D sufficiency will be assessed as the percentage of participants with a vitamin D level >30 ng/ml.
|
Month 6
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Larry Greenbaum, MD, PhD、Emory University
出版物と役立つリンク
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00067067
- EmoryPedNeph-001 (その他の識別子：Other)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
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