Chronic Kidney Disease Stage 1, Chronic Kidney Disease Stage 2
Conditions
Keywords
Chronic Kidney Disease, Vitamin D, Hepcidin, Ferritin, Vitamin D3
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.
Interventions
DRUGVitamin D
2000 IU of Vitamin D
Sponsors
Hasanuddin University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Indonesia
Outcome results
None listed