Ain Shams University
Cairo, Egypt
Location status: Recruiting
NCT Number: NCT07813975
To study the value of vitamin D supplementation on healing bed sores in ICU patients.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Cairo, Egypt
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
50000 I.U. of vitamin d3 dissolved in 45 mL of milk daily for 5 consecutive days (total dose of 250,000 I.U.)
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Maha Salah
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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