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Completed

NCT Number: NCT04536831

The Association of Vitamin D Supplementation With the Outcome in Critically Ill Children

Vitamin D deficiency is highly prevalent in critically ill adult and pediatric population that causes multiple adverse health outcomes including higher illness severity score, increased morbidity and mortality, multiple organ dysfunction, longer duration of Mechanical ventilation, longer duration of Oxygen therapy and increased length of stay (LOS) in PICU and hospital. Vitamin D deficiency is a modifiable risk factor that can be corrected with high dose of vitamin D supplementation to improve the clinical outcome.

This study is designed to determine whether random vitamin D supplementation within dose limits improves clinical outcomes in critically ill children.

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Key information

Age range

6 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

King Edward Medical University Lahore

Lahore, Punjab Province, 39500, Pakistan

About this study

Vitamin D is known for its role in bone metabolism and calcium haemostasis but it is also required for the optimal functioning of cardiovascular and innate immune systems.

As a pleiotropic hormone it has been increasingly implicated in proper functioning of multiple organs; its deficiency is associated with cardiovascular diseases, asthma, cancer, multiple sclerosis, diabetes and acute lower respiratory tract infections. Over one billion people are vitamin D deficient worldwide and in Pakistani population vitamin D deficiency is reported as high as 76% despite abundant sunshine.

Beside of ambulatory individuals, the patients presenting in intensive care units are also found Vitamin D deficient. In adult intensive care settings studies have shown vitamin D deficiency (VDD) present in 60% of critically ill adult patients.VDD is also very common in pediatric intensive care units (PICU) worldwide, ranging from 30 to 80%.

Although there is high prevalence of VDD in pediatric and adult population, but there is no uniform definition of VDD exists. Levels of active metabolite 1,25(OH)2D of Vitamin D at tissue level cannot be measured, however, patient's blood level of 25-hydroxy vitamin D is used to know vitamin D stores in the body. Patient with serum vitamin D level<20ng/ml is considered to be vitamin D deficient.

VDD is associated with clinically poor outcomes like increased duration of mechanical ventilation, increased length of hospital stay, Sepsis, Acute respiratory failure and mortality in critically ill patients.

The existing evidences suggest that Vitamin D3 supplementation enhances recovery from influenza, recurrent pneumonias and tuberculosis. Recently, an observational study of adult patients suggested that patients with VDD showed decrease in the odds of all cause-mortality when their Vitamin D status was improved before hospitalization.

A randomized study demonstrated that one time bolus dose of oral vitamin D supplementation caused decrease in mortality in a group of patients with severe VDD.

A significant literature is available that suggests vitamin D deficiency as a modifiable risk factor in PICU settings. The recognized importance of vitamin D to the health of multiple organ systems suggest that rapid normalization could represent a simple, inexpensive, and safe means of improving outcomes and reducing health care spending.

This study is designed to supplement large dose of vitamin D that may lead to fast correction of low vitamin D level in critically ill children and possibility of better clinical outcome. If such an association is established by this study, routine detection and use of Vitamin D might be recommended for critically ill children admitted to PICU.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children of age 6 months to 10 years, either gender admitted in ICU for critical illness (on medical record) with PIM-2 score suggesting probability of mortality more than 50%.

Exclusion criteria

  • Children with known adrenal, pituitary, hypothalamic or thyroid disease.
  • Those who have complex congenital defects.
  • Moribund at time of admission.
  • Those who were expected to be care withdrawn.
  • Patients who had received large dose regimen (200,000 IU or more) of vitamin D during the previous three months before admission.

Treatment and study plan

Vitamin D

Drug

Vitamin D will be given to group A selected by Lottery method

Other names: vitamin D3

normal saline

Drug

Vitamin D will be given to group B slected by Lottery method

Primary outcomes

  1. Death

    Time frame: upto one month

    Patient is declared dead by duty doctor

  2. Discharge

    Time frame: upto one month

    Patient became vitally stable and shifted out of PICU

Secondary outcomes

  1. Duration of O2 therapy

    Time frame: upto one month

    Total time that patient required O2

  2. Duration of Mechanical ventilation

    Time frame: upto one month

    Total time of Mechanical ventilation required by the patient

  3. Duration of PICU stay

    Time frame: upto one month

    Total Duration of stay in PICU

  4. Duration of Hospital stay.

    Time frame: upto one month

    Total duration of Hospital stay in wards except PICU stay

Sponsors and collaborators

Lead sponsor

Dr Mustahsin Khalil

Other

Collaborators

  • King Edward Medical University

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 3, 2020
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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