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

Phase 2

Completed

• Conditions: Chronic Kidney Disease Stage 1; Chronic Kidney Disease Stage 2
• Interventions: Drug: Vitamin D

• Registration Number: NCT06706271
• Lead Sponsor: Hasanuddin University

Brief Summary

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.

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 Timeline

• Study Start: 2023-05-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-09-02
• Status Verified: 2024-11
• Study First Submitted: 2024-11-23
• Study First Submitted QC: 2024-11-23
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Vitamin D Level	From enrollment to the end of treatment at 6 weeks	Vitamin D is measured before and after supplementation of Vitamin D
Ferritin Level	From enrollment to the end of treatment at 6 weeks	Ferritin level before and after Vitamin D supplementation
Hepcidin level	From enrollment to the end of treatment at 6 weeks	Hepcidin level before and after Vitamin D supplementation

Trial Locations

Locations (1)

Wahidin Sudirohusodo Hospital; 🇮🇩 Makassar, South Sulawesi, Indonesia