Comparison of Two Vitamin D3 Doses (500,000 IU vs 750,000 IU) in Critically Ill Patients with Vitamin D Deficiency Receiving Continuous Renal Replacement Therapy

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What is this study about?

This study focuses on patients with severe Vitamin D3 deficiency who are critically ill and receiving continuous renal replacement therapy (a treatment that helps filter waste from the blood when the kidneys are not working properly). The study compares two different doses of vitamin D3 (also known as colecalciferol) given as oral drops through a feeding tube or by mouth to these patients.

The purpose of this research is to determine how effectively two different doses of vitamin D3 (500,000 IU and 750,000 IU) can increase vitamin D levels in the blood. The medication being used is Devikap, which comes as an oral solution in the form of drops. Patients will receive a single dose of the medication and will be monitored for several days afterward.

During the study, doctors will check vitamin D levels in the blood and monitor various aspects of patient health. The study will track how patients respond to the treatment, including their recovery progress and any changes in their condition. This research is particularly important for critically ill patients who often have very low vitamin D levels while receiving kidney support treatment.

1 Initial vitamin D3 level measurement

Your blood will be tested to measure vitamin D3 levels. This test will be performed at the hospital laboratory.

You must have a vitamin D3 level of 12.5 ng/ml or lower to continue in the study.

2 Vitamin D3 administration

You will receive a single dose of vitamin D3 (Devikap) through a feeding tube or by mouth.

The dose will be either 500,000 IU or 750,000 IU of vitamin D3 oral drops solution.

3 Day 3 follow-up

Blood tests will be performed to check your vitamin D3 levels

Your blood calcium levels will be monitored

Your organ function will be assessed using a special scoring system (SOFA score)

4 Day 7 follow-up

Additional blood tests will check your vitamin D3 levels

Your blood calcium levels will be monitored again

Your organ function will be reassessed (SOFA score)

5 Day 28 assessment

Your health status will be evaluated

The duration of your intensive care unit stay will be recorded

The length of time you needed special kidney treatment (continuous renal replacement therapy) will be documented

6 Final assessment – Day 90

Final health status evaluation will be performed

This marks the end of your participation in the study

Who Can Join the Study?

Must be at least 18 years old
Must have a severe vitamin D3 deficiency with blood levels of 25(OH)D3 equal to or below 12.5 ng/ml, confirmed by hospital laboratory tests
Must be receiving continuous renal replacement therapy (a treatment that helps filter blood when kidneys are not working properly) due to at least one of these conditions:
- Acute kidney injury
- High potassium levels in blood
- Severe acid levels in blood
- Fluid in lungs
- Uremia complications (bleeding problems or heart sac inflammation)
- Excess fluid in body
Must have a SOFA score (a measure of organ failure) of at least 5 when entering the study
Must be able to receive nutrition through a feeding tube or by mouth at any amount
Can be either male or female

Who Cannot Join the Study?

Age below 18 years or above 75 years
Known hypersensitivity (allergic reaction) to vitamin D3 or any components of the supplement
Pregnant or breastfeeding women
Patients with hypercalcemia (high levels of calcium in the blood)
Patients with severe liver disease
Patients not receiving continuous renal replacement therapy (a type of dialysis treatment)
Patients unable to receive medication through a feeding tube or by mouth
Patients with active tuberculosis (TB infection)
Patients taking medications that could interact with vitamin D3 metabolism
Patients participating in other clinical trials
Patients with disorders affecting vitamin D absorption
Patients who received high-dose vitamin D supplementation in the past 3 months
Patients with sarcoidosis (an inflammatory disease affecting multiple organs)

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Uniwersytecki Szpital Kliniczny W Opolu	Opole	Poland
Skqzhqyulrh Pqguvtbmy Sjirtql Klkducbyo Nb 1 Ihpajaxufqelvpwocs Sxcidli Sspxkiwnv Unmqkqlcjwnl Mgwonyzyii W Knpxrhyxcv	Zabrze	Poland
5 Wnozmlbf Sjgcnsf Kohzhevqr Z Pemcrfzkoek Svqiamtgshx Pogbjlqfx Zqryox Obdxbn Zjgaryhcle W Knljkaqj	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	18.11.2022

Trial locations

Investigated drugs:

Colecalciferol

Vitamin D3 (cholecalciferol) is a vital nutrient that helps your body absorb calcium and maintain strong bones. In this trial, it is given to critically ill patients who are receiving kidney dialysis treatment. The vitamin is administered through a feeding tube or taken by mouth. This supplementation is particularly important for patients with severe vitamin D3 deficiency who are in intensive care and undergoing continuous kidney treatment.

Investigated diseases:

Vitamin D deficiency

Vitamin D3 Deficiency – A condition that occurs when the body has insufficient levels of vitamin D3, an essential nutrient needed for bone health and other bodily functions. The body typically gets vitamin D3 through sunlight exposure, certain foods, or supplements. When levels become too low, it can affect how the body absorbs and uses calcium and phosphorus. This deficiency can develop gradually and may be more common in people who have limited sun exposure, darker skin, or certain medical conditions. In severe cases, particularly in intensive care settings, the deficiency can become significantly pronounced due to various factors including reduced sun exposure and medical treatments like continuous renal replacement therapy.

Trial ID:

2024-510834-42-00

Protocol code:

NephroD_2021

Trial Phase:

Therapeutic confirmatory (Phase III)

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