Skip to main content
OpenTrials
Completed

NCT Number: NCT06706271

The Effect of Vitamin D3 Supplementation on Hepcidin and Ferritin Serum Levels in Children With Chronic Kidney Disease

The goal of this clinical trial is to analyze the effects of in vitamin D3 on serum hepcidin and ferritin levels among children with chronic kidney disease. The main questions it aims to answer is:

"What is the effect of giving vitamin D3 on serum hepcidin and ferritin levels in children with chronic kidney disease?"

We will compare the effect of vitamin D3 administration on hepcidin and ferritin between 2 groups. Group A consists of children with GFR more 90 mL/min/1,73 m2. Group B consists of children with GFR less than 90 mL/min/1,73 m2

Participants will be given the same 2000 IU of Vitamin D/day for 6 weeks.

Completed

Looking for future studies?

Notify Me

Key information

About this study

The primary objective of the study is to analyze the effects of vitamin D3 administration on serum levels of hepcidin and ferritin in children diagnosed with CKD. The research aims to measure these serum levels before and after vitamin D3 supplementation across different stages of kidney function, categorized by glomerular filtration rate (GFR). Specifically, it seeks to determine whether vitamin D3 can effectively reduce hepcidin levels and improve iron status as indicated by ferritin levels. The study employs a structured methodology involving children with CKD, divided into two groups based on their GFR: those with GFR < 90 mL/min/1.73 m² and those with GFR ≥ 90 mL/min/1.73 m². Serum levels of vitamin D, hepcidin, and ferritin will be measured at baseline (before supplementation) and after a defined period of vitamin D3 administration. The research will utilize statistical analyses to compare these values within and between groups to establish any significant changes attributable to the supplementation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 2 to 18 years diagnosed with chronic kidney diseases at Dr. Wahidin Sudirohusodo hospital
  • Parents have signed their child's consent to participate in the study

Exclusion criteria

  • History of blood transfusion 3 months prior
  • Liver dysfunction
  • Sepsis
  • Routine consumption of Vitamin D
  • Routine consumption of iron supplement
  • Patients diagnosed with iron deficiency anemia

Treatment and study plan

Vitamin D

Drug

2000 IU of Vitamin D

Primary outcomes

  1. Vitamin D Level

    Time frame: From enrollment to the end of treatment at 6 weeks

    Vitamin D is measured before and after supplementation of Vitamin D

  2. Ferritin Level

    Time frame: From enrollment to the end of treatment at 6 weeks

    Ferritin level before and after Vitamin D supplementation

  3. Hepcidin level

    Time frame: From enrollment to the end of treatment at 6 weeks

    Hepcidin level before and after Vitamin D supplementation

Sponsors and collaborators

Lead sponsor

Hasanuddin University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 26, 2024
Registry last updated
Nov 27, 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.

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