Skip to main content
OpenTrials
Completed

NCT Number: NCT05434377

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vitamin D Deficiency Avitaminosis Chronic Disease Deficiency Diseases Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chulalongkorn Univeristy

Bangkok, Thailand

About this study

The investigators plan to conduct a randomized study comparing the two different protocols between serum 25(OH)D level-based titration regimen and fixed dose of ergocalciferol supplementation among dialysis patients for a total period of 6 months. At the study completion, investigators also plan to compare the proportion of participants achieving serum 25(OH)D of more than 30 ng/ml, CKD-related metabolic and bone parameters as well as non-skeletal effect of vitamin D supplementation for each group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ergocalciferol supplementation

Other

Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.

Other names: nutritional vitamin D supplementation

dialysis techniques

Other

Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.

Other names: mode of dialysis

sunlight exposure time

Other

Both groups will be advised to receive similar hours of daily sunlight exposure time.

Primary outcomes

  1. proportion of patients with vitamin D adequacy

    Time frame: 6 months

    serum 25(OH)D more than 30 ng/ml

Secondary outcomes

  1. serum calcium

    Time frame: 6 months

    pre-dialysis serum calcium levels

  2. serum phosphorus

    Time frame: 6 months

    pre-dialysis serum phosphorus levels

  3. serum intact parathyroid hormone

    Time frame: 6 months

    pre-dialysis serum intact parathyroid hormone levels

  4. muscle mass

    Time frame: 6 months

    bioimpedance-derived muscle mass measurement

  5. muscle strength

    Time frame: 6 months

    handgrip strength measurement

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

A Randomized Study Comparing Between Fixed Dose and Serum Level-Based Titration Regimen of Vitamin D Supplementation Among Dialysis Patients

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2022
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.