Bed Sores
Conditions
Keywords
bed sores, vitamin D, ICU, NPUAP
Brief summary
To study the value of vitamin D supplementation on healing bed sores in ICU patients.
Detailed description
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.
Interventions
DRUGEnteral Vit-D 3 (cholecalciferol)
50000 I.U. of vitamin d3 dissolved in 45 mL of milk daily for 5 consecutive days (total dose of 250,000 I.U.)
Sponsors
Maha Salah
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
1. Refusal of the legal guardian of the patient to participate in the study. 2. Current pregnancy or lactating mother. 3. Patients who are terminally ill and expected to die in less than 72 hours. 4. Renal dysfunction (GFR \< 30 mL/min) and the onset of dialysis during the study. 5. Vitamin D supplementation in the last 15 days. 6. Hypo/hyper-calcemia (adjusted calcium less than 8 mg/dL or above 10). 7. History of disorders associated with hypercalcemia (history of cancer with history of hypercalcemia within the past 1 year, hyperparathyroidism, sarcoidosis, nephrolithiasis). 8. History of parathyroid dysfunction. 9. Ongoing shock, \[defined as unstable blood pressure despite vasopressor support and mean arterial pressure (MAP) \< 60 mm Hg on at least 3 consecutive readings within a 3-hour period prior to study entry\]. 10. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pressure Ulcer Healing From Baseline to Day 7, Assessed Using the Pressure Ulcer Scale for Healing (PUSH) Tool | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
Egypt
Contacts
CONTACTMaha Salah Dr., lecturer
Outcome results
None listed