An interventional study of Enteral Vit-D 3 (cholecalciferol) in Bed Sores, sponsored by Maha Salah. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Maha Salah · Not applicable, Interventional, and Supportive care
To study the value of vitamin D supplementation on healing bed sores in ICU patients.
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.
545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 405 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →This is the only study on the registry with Maha Salah as lead sponsor.
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exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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).
Drug: Enteral Vit-D 3 (cholecalciferol)
No exogenous Vitamin D will be taken.
50000 I.U. of vitamin d3 dissolved in 45 mL of milk daily for 5 consecutive days (total dose of 250,000 I.U.)
Change in Pressure Ulcer Healing From Baseline to Day 7, Assessed Using the Pressure Ulcer Scale for Healing (PUSH) Tool
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 after initiation of the study intervention.
Mean Change in Plasma 25-Hydroxyvitamin D [25(OH)D] Concentration From Baseline to Day 7
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.
Time frame: Baseline (Day 0) to Day 7 - approximately 7 days after initiation/administration of the study intervention.
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Mar 2027, 6 months after the start.
Of 179 non-industry interventional studies with no phase under Pressure Ulcer, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 6 months is below that.
Counting every sponsor, half of 209 studies reached it within 11 months; a quarter within 5 and three quarters within 28.
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Studies of the drug tested here: Cholecalciferol