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

August 27, 2020 updated by: Dr Mustahsin Khalil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 39500
        • King Edward Medical University Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D group
Consisted of 48 patients selected on admission via lottery method those will be given Vitamin D mega dose
Drug: Vitamin D
Vitamin D will be given to group A selected by Lottery method
Other Names:
  • vitamin D3
Placebo Comparator: Normal Saline group
Consisted of 48 patients selected on admission via lottery method those will be given Normal saline
Drug: Normal saline
Vitamin D will be given to group B slected by Lottery method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: upto one month
Patient is declared dead by duty doctor
upto one month
Discharge
Time Frame: upto one month
Patient became vitally stable and shifted out of PICU
upto one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of O2 therapy
Time Frame: upto one month
Total time that patient required O2
upto one month
Duration of Mechanical ventilation
Time Frame: upto one month
Total time of Mechanical ventilation required by the patient
upto one month
Duration of PICU stay
Time Frame: upto one month
Total Duration of stay in PICU
upto one month
Duration of Hospital stay.
Time Frame: upto one month
Total duration of Hospital stay in wards except PICU stay
upto one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Mustahsin Khalil

Collaborators

King Edward Medical University

Investigators

  • Principal Investigator: Mustahsin khalil Ahmad, MBBS, KEMU Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2019

Primary Completion (Actual)

February 25, 2020

Study Completion (Actual)

February 25, 2020

Study Registration Dates

First Submitted

August 21, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (Actual)

September 3, 2020

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

August 27, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKA1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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