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

Hasanuddin University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Kidney Disease Stage 2; Chronic Kidney Disease Stage 1

Treatments: Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT06706271

C105201005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

GFR more than 90 mL/min/1,73 m2

Experimental group

Description:

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

Treatment:

Drug: Vitamin D

GFR less than 90 mL/min/1,73 m2

Experimental group

Description:

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

Treatment:

Drug: Vitamin D