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

NCT ID: NCT06706271

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-09-02

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease Stage 1 Chronic Kidney Disease Stage 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

2000 IU of Vitamin D

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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

2000 IU of Vitamin D

Interventions

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Vitamin D

2000 IU of Vitamin D

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hasanuddin University

OTHER

Sponsor Role lead

Responsible Party

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Andi Muldiana Dwi Rachmayani

Pediatric Resident, Department of Pediatric

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andi Muldiana Dwi Rachmayani, MD

Role: PRINCIPAL_INVESTIGATOR

Hasanuddin University

Locations

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Wahidin Sudirohusodo Hospital

Makassar, South Sulawesi, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type BACKGROUND
PMID: 30008129 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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https://pubmed.ncbi.nlm.nih.gov/30008129/

Related Info

Other Identifiers

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C105201005

Identifier Type: -

Identifier Source: org_study_id