CompletedNot Applicable

A Study of Fixed Dose Versus Serum Level-Based Titration Regimen of Vitamin D Supplementation in Dialysis Patients

Thailand78 participantsStarted 2022-08-01

Plain-language summary

Vitamin D insufficiency, defined as serum 25-hydroxyvitamin (OH) D level less than 30 ng/ml, is highly prevalent not only in the general population but also in chronic kidney disease (CKD) population. Many guidelines including the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) have consistently recommended vitamin D supplementation in patients with pre-dialysis CKD with vitamin D insufficiency with ergocalciferol or cholecalciferol to achieve 25(OH)D level of more than 30 ng/ml using serum levels-based titration regimen. However, this protocol has not been studied in end stage kidney disease patients treated with maintenance dialysis.

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age \> 18 years * on maintenance dialysis (hemodialysis or peritoneal dialysis) \> 3 months * 25(OH)D \< 30 ng/ml * able to provide inform consent form Exclusion Criteria: * current ergocalciferol or cholecalciferol treatment * known allergy to ergocalciferol * active inflammation or infection * advanced stage of cancer * pregnancy * lactation * on immunosuppressive drugs or corticosteroids

What they're measuring

proportion of patients with vitamin D adequacy

Timeframe: 6 months

Trial details

NCT IDNCT05434377

SponsorChulalongkorn University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-31

View on ClinicalTrials.gov More Vitamin D Deficiency trials