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

NCT06706271 | Completed Phase 2

• 1 other identifier: C105201005
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease Stage 1; Chronic Kidney Disease Stage 2

Keywords

Chronic Kidney Disease; Vitamin D; Hepcidin; Ferritin; Vitamin D3

Outcome Measures

Primary Outcomes (3)

• Vitamin D Level

  Vitamin D is measured before and after supplementation of Vitamin D

  From enrollment to the end of treatment at 6 weeks

• Ferritin Level

  Ferritin level before and after Vitamin D supplementation

  From enrollment to the end of treatment at 6 weeks

• Hepcidin level

  Hepcidin level before and after Vitamin D supplementation

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

Vitamin D DRUG

2000 IU of Vitamin D

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

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Wahidin Sudirohusodo Hospital

Makassar, South Sulawesi, 90245, Indonesia

Location

Related Publications (1)

• Altemose KE, Kumar J, Portale AA, Warady BA, Furth SL, Fadrowski JJ, Atkinson MA. Vitamin D insufficiency, hemoglobin, and anemia in children with chronic kidney disease. Pediatr Nephrol. 2018 Nov;33(11):2131-2136. doi: 10.1007/s00467-018-4020-5. Epub 2018 Jul 14.

  PMID: 30008129 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Andi Muldiana Dwi Rachmayani, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Resident, Department of Pediatric

Model Details: The study targets children diagnosed with chronic kidney disease, categorized into two groups based on their glomerular filtration rate (GFR): those with GFR \< 90 mL/min/1.73 m² and those with GFR ≥ 90 mL/min/1.73 m². Participants are selected through purposive sampling, ensuring they meet defined inclusion criteria related to age, CKD diagnosis, and baseline serum levels. Serum levels of vitamin D, hepcidin, and ferritin are measured before and after vitamin D3 supplementation. This allows for comparative analysis of changes within each group and between the two groups, providing insights into the effects of vitamin D3 on iron metabolism.

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: November 26, 2024
• Study Start: May 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: September 2, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)