Evaluating the Impact of Vitamin D Supplementation on Healing Bed Sores in ICU.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Pressure Ulcer Healing From Baseline to Day 7, Assessed Using the Pressure Ulcer Scale for Healing (PUSH) Tool
研究概览
简要总结
To study the value of vitamin D supplementation on healing bed sores in ICU patients.
详细描述
Vitamin D deficiency is a prevalent and clinically significant factor associated with adverse outcomes in critically ill patients, including increased mortality, prolonged hospital stays, and delayed wound healing, particularly pressure ulcers. Given the established link between low vitamin D levels (25-hydroxyvitamin D [25(OH)D] < 20 ng/mL) and these complications, this study aims to investigate the impact of a high-dose vitamin D3 supplementation regimen (250,000 IU over five days) on facilitating Bed Sores healing in ICU patients. By elevating 25(OH)D concentrations to a therapeutic range (>30 ng/mL), we hypothesize that this intervention will contribute to enhanced patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •7- Serum Calcium (8-10 mg/dl). 8- Serum creatinine less than 1.4 mg/dL.
排除标准
- •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.
- •known history of cirrhosis.
- •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).
研究组 & 干预措施
Group A (Intervention group)
- Patients will receive Enteral Vit-D 3 (cholecalciferol) supplementation.
- One tablet of Biodal ® containing 50000 I.U. of vitamin d3 dissolved in 45 mL of milk daily for 5 consecutive days (total dose of 250,000 I.U.).
- This group will be monitored during the study for Vitamin D toxicity symptoms & signs of including: vomiting (treated by giving anti emetic ondansetron IV), constipation (treated by giving lactulose syrup as laxative), irritability, Hypercalcemia and Renal impairment (treated by restricting vitamin D and calcium supplements, and fluid adjustment).
干预措施: Enteral Vit-D 3 (cholecalciferol) (Drug)
Group B (Control Group)
No exogenous Vitamin D will be taken.
结局指标
主要结局
Change in Pressure Ulcer Healing From Baseline to Day 7, Assessed Using the Pressure Ulcer Scale for Healing (PUSH) Tool
时间窗: Baseline (Day 0) to Day 7 after initiation of the study intervention.
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.
次要结局
- Mean Change in Plasma 25-Hydroxyvitamin D [25(OH)D] Concentration From Baseline to Day 7(Baseline (Day 0) to Day 7 - approximately 7 days after initiation/administration of the study intervention.)
研究者
Maha Salah
principal investigator
Ain Shams University