Evaluating the Impact of Vitamin D Supplementation on Healing Bed Sores in ICU.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maha Salah Dr., lecturer
- Phone Number: +201007269331
- Email: mahata5deer@gmail.com
Study Locations
-
-
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Cairo, Egypt
- Recruiting
- Ain Shams University
-
Contact:
- Maha Salah Dr., lecturer
- Phone Number: +201007269331
- Email: mahata5deer@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: 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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No Intervention: Group B (Control Group)
No exogenous Vitamin D will be taken.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pressure Ulcer Healing From Baseline to Day 7, Assessed Using the Pressure Ulcer Scale for Healing (PUSH) Tool
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. |
Baseline (Day 0) to Day 7 after initiation of the study intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Change in Plasma 25-Hydroxyvitamin D [25(OH)D] Concentration From Baseline to Day 7
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. |
Baseline (Day 0) to Day 7 - approximately 7 days after initiation/administration of the study intervention.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU MS 434/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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