Evaluating the Impact of Vitamin D Supplementation on Healing Bed Sores in ICU.
調査の概要
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Maha Salah Dr., lecturer
- 電話番号：+201007269331
- メール：mahata5deer@gmail.com
研究場所
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Cairo、エジプト
- 募集
- Ain Shams University
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コンタクト：
- Maha Salah Dr., lecturer
- 電話番号：+201007269331
- メール：mahata5deer@gmail.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
inclusion criteria:
1-Critically ill patients with bed sores Grade (1-2), (non-light) exudate admitted to ICUs.
2- Serum vitamin D <20 ng/mL. 3- Both genders. 4- Age: 18-60 years. 5- enteral access in place to enable delivery of vitamin D3 and are deemed to be able to tolerate enteral drug administration.
6- GCS > 9. 7- Serum Calcium (8-10 mg/dl). 8- Serum creatinine less than 1.4 mg/dL. exclusion criteria:
- Refusal of the legal guardian of the patient to participate in the study.
- Current pregnancy or lactating mother.
- Patients who are terminally ill and expected to die in less than 72 hours.
- Renal dysfunction (GFR < 30 mL/min) and the onset of dialysis during the study.
- Vitamin D supplementation in the last 15 days.
- Hypo/hyper-calcemia (adjusted calcium less than 8 mg/dL or above 10).
- History of disorders associated with hypercalcemia (history of cancer with history of hypercalcemia within the past 1 year, hyperparathyroidism, sarcoidosis, nephrolithiasis).
- History of parathyroid dysfunction.
- Ongoing shock, [defined as unstable blood pressure despite vasopressor support and mean arterial pressure (MAP) < 60 mm Hg on at least 3 consecutive readings within a 3-hour period prior to study entry].
- History of malabsorption syndromes; gastrointestinal intolerance (diarrhea, vomiting, or increased nasogastric aspirates).
11. History of adverse reaction to vitamin D supplementation. 12. known history of cirrhosis. 13. Patients taking any medications that have serious drug interactions with vitamin D like statins, orlistat, aluminum hydroxide (interfere with the absorption of vitamin D), digoxin (can enhance the effects of vitamin D on the heart leading to potential toxicity), and certain diuretics (can cause high calcium levels).
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：支持療法
- 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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アクティブコンパレータ：Group A (Intervention group)
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50000 I.U. of vitamin d3 dissolved in 45 mL of milk daily for 5 consecutive days (total dose of 250,000 I.U.)
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介入なし：Group B (Control Group)
No exogenous Vitamin D will be taken.
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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 Pressure Ulcer Healing From Baseline to Day 7, Assessed Using the Pressure Ulcer Scale for Healing (PUSH) Tool
時間枠：Baseline (Day 0) to Day 7 after initiation of the study intervention.
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Pressure ulcer healing will be assessed using the Pressure Ulcer Scale for Healing (PUSH). The PUSH tool evaluates wound healing based on wound length × width (surface area), wound exudate amount, and tissue type. A total PUSH score is calculated, with lower scores indicating better healing. The change in PUSH score from baseline to Day 7 will be used to evaluate improvement in pressure-ulcer healing. Calculation: Change in PUSH score = PUSH score at Day 7 - PUSH score at baseline A negative change indicates improvement/healing, whereas a positive change indicates deterioration. |
Baseline (Day 0) to Day 7 after initiation of the study intervention.
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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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Mean Change in Plasma 25-Hydroxyvitamin D [25(OH)D] Concentration From Baseline to Day 7
時間枠：Baseline (Day 0) to Day 7 - approximately 7 days after initiation/administration of the study intervention.
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The mean change in plasma 25(OH)D concentration from baseline (Day 0, before administration of the study intervention) to Day 7. The change is calculated as: Change = 25(OH)D concentration at Day 7 - 25(OH)D concentration at baseline The outcome is generally reported in ng/mL (or nmol/L). A positive change indicates an increase in vitamin D concentration, while a negative change indicates a decrease. |
Baseline (Day 0) to Day 7 - approximately 7 days after initiation/administration of the study intervention.
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
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