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

NCT04536831 | Completed Phase 4 DMC

• 1 other identifier: MKA1
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critically Ill

Keywords

vitamin D; Supplimentation; Critically ill children

Outcome Measures

Primary Outcomes (2)

• Death

  Patient is declared dead by duty doctor

  upto one month

• Discharge

  Patient became vitally stable and shifted out of PICU

  upto one month

Secondary Outcomes (4)

• Duration of O2 therapy

  upto one month

• Duration of Mechanical ventilation

  upto one month

• Duration of PICU stay

  upto one month

• Duration of Hospital stay.

  upto one month

Study Arms (2)

Vitamin D group

EXPERIMENTAL

Consisted of 48 patients selected on admission via lottery method those will be given Vitamin D mega dose

Drug: Vitamin D

Normal Saline group

PLACEBO COMPARATOR

Consisted of 48 patients selected on admission via lottery method those will be given Normal saline

Drug: Normal saline

Interventions

Vitamin D DRUG

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

Also known as: vitamin D3

Vitamin D group

Normal saline DRUG

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

Normal Saline group

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Mustahsin Khalil: lead
• King Edward Medical University: collaborator

Study Sites (1)

King Edward Medical University Lahore

Lahore, Punjab Province, 39500, Pakistan

Location

Related Publications (16)

• McNally JD, Menon K, Chakraborty P, Fisher L, Williams KA, Al-Dirbashi OY, Doherty DR; Canadian Critical Care Trials Group. The association of vitamin D status with pediatric critical illness. Pediatrics. 2012 Sep;130(3):429-36. doi: 10.1542/peds.2011-3059. Epub 2012 Aug 6.

  PMID: 22869837 BACKGROUND

• McNally JD, Iliriani K, Pojsupap S, Sampson M, O'Hearn K, McIntyre L, Fergusson D, Menon K. Rapid normalization of vitamin D levels: a meta-analysis. Pediatrics. 2015 Jan;135(1):e152-66. doi: 10.1542/peds.2014-1703. Epub 2014 Dec 15.

  PMID: 25511115 BACKGROUND

• Hossain N, Khanani R, Hussain-Kanani F, Shah T, Arif S, Pal L. High prevalence of vitamin D deficiency in Pakistani mothers and their newborns. Int J Gynaecol Obstet. 2011 Mar;112(3):229-33. doi: 10.1016/j.ijgo.2010.09.017. Epub 2011 Jan 17.

  PMID: 21247568 BACKGROUND

• Mahmood K, Akhtar ST, Talib A, Haider I. Vitamin-D status in a population of healthy adults in Pakistan. Pak J Med Sci. 2009;25(4):545-50.

  BACKGROUND

• Riaz H, Finlayson AE, Bashir S, Hussain S, Mahmood S, Malik F, Godman B. Prevalence of Vitamin D deficiency in Pakistan and implications for the future. Expert Rev Clin Pharmacol. 2016;9(2):329-38. doi: 10.1586/17512433.2016.1122519. Epub 2016 Jan 13.

  PMID: 26582317 BACKGROUND

• Amrein K, Schnedl C, Holl A, Riedl R, Christopher KB, Pachler C, Urbanic Purkart T, Waltensdorfer A, Munch A, Warnkross H, Stojakovic T, Bisping E, Toller W, Smolle KH, Berghold A, Pieber TR, Dobnig H. Effect of high-dose vitamin D3 on hospital length of stay in critically ill patients with vitamin D deficiency: the VITdAL-ICU randomized clinical trial. JAMA. 2014 Oct 15;312(15):1520-30. doi: 10.1001/jama.2014.13204.

  PMID: 25268295 BACKGROUND

• McNally D, Amrein K, O'Hearn K, Fergusson D, Geier P, Henderson M, Khamessan A, Lawson ML, McIntyre L, Redpath S, Weiler HA, Menon K; Canadian Critical Care Trials Group. Study protocol for a phase II dose evaluation randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study). Pilot Feasibility Stud. 2017 Dec 8;3:70. doi: 10.1186/s40814-017-0214-z. eCollection 2017.

  PMID: 29234503 BACKGROUND

• Angurana SK. Serum Vitamin D Status and Outcome among Critically Ill Children Admitted to the Pediatric Intensive Care Unit in South India: Correspondence. Indian J Pediatr. 2016 Aug;83(8):910-1. doi: 10.1007/s12098-015-1992-z. Epub 2016 Jan 14. No abstract available.

  PMID: 26762331 BACKGROUND

• Madden K, Feldman HA, Smith EM, Gordon CM, Keisling SM, Sullivan RM, Hollis BW, Agan AA, Randolph AG. Vitamin D deficiency in critically ill children. Pediatrics. 2012 Sep;130(3):421-8. doi: 10.1542/peds.2011-3328. Epub 2012 Aug 6.

  PMID: 22869836 BACKGROUND

• Han JE, Jones JL, Tangpricha V, Brown MA, Brown LAS, Hao L, Hebbar G, Lee MJ, Liu S, Ziegler TR, Martin GS. High Dose Vitamin D Administration in Ventilated Intensive Care Unit Patients: A Pilot Double Blind Randomized Controlled Trial. J Clin Transl Endocrinol. 2016 Jun;4:59-65. doi: 10.1016/j.jcte.2016.04.004. Epub 2016 May 5.

  PMID: 27419080 BACKGROUND

• Amrein K, Litonjua AA, Moromizato T, Quraishi SA, Gibbons FK, Pieber TR, Camargo CA Jr, Giovannucci E, Christopher KB. Increases in pre-hospitalization serum 25(OH)D concentrations are associated with improved 30-day mortality after hospital admission: A cohort study. Clin Nutr. 2016 Apr;35(2):514-521. doi: 10.1016/j.clnu.2015.03.020. Epub 2015 Apr 14.

  PMID: 25935851 BACKGROUND

• Amrein K, Sourij H, Wagner G, Holl A, Pieber TR, Smolle KH, Stojakovic T, Schnedl C, Dobnig H. Short-term effects of high-dose oral vitamin D3 in critically ill vitamin D deficient patients: a randomized, double-blind, placebo-controlled pilot study. Crit Care. 2011;15(2):R104. doi: 10.1186/cc10120. Epub 2011 Mar 28.

  PMID: 21443793 BACKGROUND

• Williams S, Heuberger R. Outcomes of Vitamin D Supplementation in Adults Who are Deficient and Critically Ill: A Review of the Literature. Am J Ther. 2016 Nov/Dec;23(6):e1890-e1902. doi: 10.1097/MJT.0000000000000281.

  PMID: 26164022 BACKGROUND

• Gandhi J, Sangareddi S, Varadarajan P, Suresh S. Pediatric index of mortality 2 score as an outcome predictor in pediatric Intensive Care Unit in India. Indian J Crit Care Med. 2013 Sep;17(5):288-91. doi: 10.4103/0972-5229.120320.

  PMID: 24339640 BACKGROUND

• Greenbaum LA. Rickets and Hypervitaminosis. In: Kliegman RM, Stanton BF, Geme III JW, Schor NF. (eds). Nelson Textbook Of Pediatrics. 20th ed. Philadelphia: Elsevier; 2016. p.331-38.

  BACKGROUND

• Balasubramanian S, Dhanalakshmi K, Amperayani S. Vitamin D deficiency in childhood-a review of current guidelines on diagnosis and management. Indian Pediatr. 2013 Jul;50(7):669-75. doi: 10.1007/s13312-013-0200-3.

  PMID: 23942432 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Vitamin D; Cholecalciferol; Saline Solution

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mustahsin khalil Ahmad, MBBS

  KEMU Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post graduate Trainee

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: September 3, 2020
• Study Start: August 29, 2019
• Primary Completion: February 25, 2020
• Study Completion: February 25, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)