Rapid normalization of Vitamin D in critically ill children: A phase II dose evaluation randomized controlled trial (VITdAL-PICU pilot) - VITdAL-PIC

Children's Hospital of Eastern Ontario0 个研究点目标入组 60 人开始时间: 2017年1月19日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•The inclusion criteria for this study are:
•Admitted to ICU,
•Corrected gestational age > 37 weeks to age < 18 years,
•Expected ICU admission in excess of 48 hours, and will have access for bloodwork at 7 days (clinical bloodwork or lines)
•Blood 25(OH)D less than 50 nmol/L (regardless of prior approach to supplementation),
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 60
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patients who meet any of the following criteria will be excluded:
•Significant gastrointestinal disorder preventing enteral drug administration (e.g. necrotizing enterocolitis);
•Hypercalcemia (excluding transient abnormalities and those related to parenteral calcium administration for hypocalcemia);
•Confirmed or suspected William’s syndrome;
•Patient known to have nephrolithiasis or Nephrocalcinosis;
•Imminent plan for withdrawal of care or transfer to another ICU;Physician refusal;
•Previous enrollment in the study;
•Patient known to have granulomatous disease (tuberculosis or sarcoidosis),
•Severe liver dysfunction/liver failure;
•Patient know to have hypersensitivity or allergy to vitamin D or any of the non-medicinal ingredients of the formulation;Patient on thiazide diuretics who is also receiving regular ongoing calcium supplementation above the daily recommended intake for reasons other than hypocalcemia;
•Adolescent female of child-bearing age with a positive serum pregnancy test; or
•Patient on digoxin-therapy

发起方