Clinical trial NCT06706271: The Effect of Vitamin D3 Supplementation on Hepcidin and Ferritin Serum Levels in Children With Chronic Kidney Disease
Official title: The Effect of Vitamin D3 Supplementation on Hepcidin and Ferritin Serum Levels in Children With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Kidney Disease Stage 1
Chronic Kidney Disease Stage 2
Keywords: Chronic Kidney Disease
Vitamin D
Hepcidin
Ferritin
Vitamin D3
Lead sponsor: Hasanuddin University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 43
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vitamin D Level
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Ferritin Level
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Hepcidin level
timeFrame: From enrollment to the end of treatment at 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Makassar
country: Indonesia
facility: Wahidin Sudirohusodo Hospital
state: South Sulawesi
Study officials:
affiliation: Hasanuddin University
name: Andi Muldiana Dwi Rachmayani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.