Chronic Kidney Disease Stage 1Phase 2/3NCT06706271
The Effect of Vitamin D3 Supplementation on Hepcidin and Ferritin Serum Levels in Children With Chronic Kidney Disease
A Phase 2/3 study testing Vitamin D in people with Chronic Kidney Disease Stage 1 and Chronic Kidney Disease Stage 2, run by Hasanuddin University at 1 site in Indonesia.
Trial 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?"… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Chronic Kidney Disease Stage 1, Chronic Kidney Disease Stage 2
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2023to 2 Sep 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Indonesia1 site
Wahidin Sudirohusodo Hospital
Makassar, South Sulawesi, 90245
About this study
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.
Read the 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.
- Being tested
- Vitamin D
- Keywords
- Chronic Kidney Disease, Vitamin D, Hepcidin, Ferritin, Vitamin D3
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
2000 IU of Vitamin D
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D Level
Vitamin D is measured before and after supplementation of Vitamin D
Measured: From enrollment to the end of treatment at 6 weeks
Ferritin Level
Ferritin level before and after Vitamin D supplementation
Measured: From enrollment to the end of treatment at 6 weeks
Hepcidin level
Hepcidin level before and after Vitamin D supplementation
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 May 2023
- Primary completion1 Aug 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Stage 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andi Muldiana Dwi Rachmayani, Hasanuddin University
- Investigators
- Andi Muldiana Dwi Rachmayani, MD, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706271
- Sponsor's protocol ID
- C105201005
- Status last verified
- Nov 2024
- First submitted
- 23 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30008129
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D3 Supplementation on Hepcidin and Ferritin Serum Levels in Children With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06706271
- Acronym / sponsor ID
- C105201005
- Keywords
- Chronic Kidney Disease, Vitamin D, Hepcidin, Ferritin, Vitamin D3
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| GFR more than 90 mL/min/1,73 m2 | Experimental | Drug: Vitamin DChildren with GFR more than 90 mL/min/1,73 m2, and will be given 2000 IU of Vitamin D for 6 weeks |
| GFR less than 90 mL/min/1,73 m2 | Experimental | Drug: Vitamin DChildren with GFR less than 90 mL/min/1,73 m2, and will be given 2000 IU of Vitamin D for 6 weeks |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- History of blood transfusion 3 months prior
- Liver dysfunction
- Sepsis
- Routine consumption of Vitamin D
- Routine consumption of iron supplement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D2000 IU of Vitamin D | Drug | GFR less than 90 mL/min/1,73 m2, GFR more than 90 mL/min/1,73 m2 |
Primary outcome
Vitamin D Level
Time frame: From enrollment to the end of treatment at 6 weeks
Vitamin D is measured before and after supplementation of Vitamin D
Ferritin Level
Time frame: From enrollment to the end of treatment at 6 weeks
Ferritin level before and after Vitamin D supplementation
Hepcidin level
Time frame: From enrollment to the end of treatment at 6 weeks
Hepcidin level before and after Vitamin D supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Background: PubMed 30008129Altemose 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andi Muldiana Dwi Rachmayani, MD principal investigator
Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vitamin D in people with Chronic Kidney Disease Stage 1 and Chronic Kidney Disease Stage 2, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D Level (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06706271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.