NCT05434377Completed
A Study of Fixed Dose Versus Serum Level-Based Titration Regimen of Vitamin D Supplementation in Dialysis Patients
A Randomized Study Comparing Between Fixed Dose and Serum Level-Based Titration Regimen of Vitamin D Supplementation Among Dialysis Patients
Source: ClinicalTrials.gov · Last updated 8 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 78 (actual)
- First submitted
- 21 Jun 2022
- Start date
- 1 Aug 2022
- Primary completion date
- 31 May 2023
- Lead sponsor
- Chulalongkorn University
- Diseases
- Chronic kidney disease
- NCT number
- NCT05434377
What you commit to
- Study type: Interventional
- Participants enrolled: 78
- From 1 Aug 2022 to the primary completion date, 31 May 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- on immunosuppressive drugs or corticosteroids
Other illness
- known allergy to ergocalciferol
- active inflammation or infection
- advanced stage of cancer
Other
- current ergocalciferol or cholecalciferol treatment
- pregnancy
- lactation
Who the study is looking for
- age \> 18 years
- on maintenance dialysis (hemodialysis or peritoneal dialysis) \> 3 months
- 25(OH)D \< 30 ng/ml
- able to provide inform consent form
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chulalongkorn Univeristy Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.