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

November 25, 2024 updated by: Andi Muldiana Dwi Rachmayani, Hasanuddin University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia, 90245
        • Wahidin Sudirohusodo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GFR more than 90 mL/min/1,73 m2
Children with GFR more than 90 mL/min/1,73 m2, and will be given 2000 IU of Vitamin D for 6 weeks
Drug: Vitamin D
2000 IU of Vitamin D
Experimental: GFR less than 90 mL/min/1,73 m2
Children with GFR less than 90 mL/min/1,73 m2, and will be given 2000 IU of Vitamin D for 6 weeks
Drug: Vitamin D
2000 IU of Vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 6 weeks
Ferritin Level
Time Frame: From enrollment to the end of treatment at 6 weeks
Ferritin level before and after Vitamin D supplementation
From enrollment to the end of treatment at 6 weeks
Hepcidin level
Time Frame: From enrollment to the end of treatment at 6 weeks
Hepcidin level before and after Vitamin D supplementation
From enrollment to the end of treatment at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasanuddin University

Investigators

  • Principal Investigator: Andi Muldiana Dwi Rachmayani, MD, Hasanuddin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

September 2, 2024

Study Registration Dates

First Submitted

November 23, 2024

First Submitted That Met QC Criteria

November 23, 2024

First Posted (Actual)

November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C105201005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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