drugset / Trial / NCT04536831
The Association of Vitamin D Supplementation With the Outcome in Critically Ill Children
Phase 4
Completed
96 enrolled
King Edward Medical University
King Edward Medical University · collab
RandomizedFactorialSingle-blindHealth-services research
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.
Timeline
- Start
- 2019-08-29
- Primary completion
- 2020-02-25
- Completion
- 2020-02-25
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vitamin D | Other / unclassified | — | — |
Indications
No indication recorded.