Chronic Kidney DiseasePhase 1NCT01909115
Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease
A Phase 1 study testing 1000 IU of Vitamin D3 and 4000 IU of Vitamin D3 in people with Chronic Kidney Disease, run by Emory University at 1 site in United States.
Trial summary
Vitamin D deficiency is common in the general population and more common in children with chronic kidney disease. Vitamin D is very important for bone health, especially in children with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 9 to 21 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- 1000 IU of Vitamin D3 and 4000 IU of Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 26 Sep 2014
- Phase
- Phase 1
- 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 9 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient's parent/legal guardian must be willing and able to give written informed consent and the patient must be willing to give written informed assent if applicable
- Estimated glomerular filtration rate < 60 mL/min/1.73 m2 body surface area or recipient of a kidney transplant
- 9-21 years old
- Able to swallow pills
Who cannot join
- Liver failure
- Malabsorption
- Current calcium level >10.5 mg/dL
- History of hypercalcemia (Ca >11 mg/dL) during the preceding 6 months
- Current treatment with an antiepileptic drug or other medications that may affect vitamin D metabolism (e.g., phenobarbital, phenytoin, rifampicin)
- History of hypervitaminosis D
- Completion of a course of high dose vitamin D within the preceding 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Childen's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: Randomized Trial of Two Maintenance Doses of Vitamin D and Trace Element Status in Children With Chronic Kidney Disease
Vitamin D deficiency is common in the general population and more common in children with chronic kidney disease. Vitamin D is very important for bone health, especially in children with chronic kidney disease. To date, several studies using different doses of vitamin D have been tried to correct vitamin D deficiency, but none has been completely successful. The investigators are comparing two different doses of vitamin D to determine which one is more effective at correcting and maintaining normal blood levels of vitamin D. The investigators hypothesize that a higher percentage of children receiving a higher dose of vitamin D will be vitamin D replete at the end of 6 months.
This study will enroll 80 children 9 to 18 years old who have chronic kidney disease (CKD) and can take pills. They will be enrolled from Chronic Renal Insufficiency Clinic, the Hemodialysis Unit, Peritoneal Dialysis Clinic and Transplant Clinic at Children's Healthcare of Atlanta.
Read the detailed description
Vitamin D has a critical role in bone metabolism. In addition, there is increasing evidence that vitamin D has an important role in many other areas, including cardiovascular health, immune function, and prevention of autoimmune diseases and certain malignancies. In patients with CKD, there are a variety of abnormalities in mineral metabolism that lead to bone disease.
After the investigators obtain informed consent and assent, children will be randomly assigned to either low dose (1000 units daily) or high dose (4000 units daily) vitamin D pills (50% in each group). Participants will take vitamin D capsules every day for for 6 months. Vitamin D levels will be obtained at baseline, 3 months and 6 months. The study visits will be at the same time as routine clinic visits when the children are having blood drawn for routine care. At the end of the study, the investigators will compare the percentage of patients who have normal vitamin D levels at 6 months in the two groups. The investigators will also describe the percentage of patients who have elevated or low levels of trace elements.
The two doses of vitamin D in this study are within the dosing range recommended by the Institute of Medicine, and thus the investigators do not anticipate any adverse effects. Vitamin D toxicity could theoretically occur, and an elevated vitamin D level at 3 months would be an indication to withdraw a patient from the study.
- Conditions
- Chronic Kidney Disease
- Being tested
- 1000 IU of Vitamin D3, 4000 IU of 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.
1000 IU of Vitamin D3Drug
1000 IU of Vitamin D will be administered in capsule form, once daily.
4000 IU of Vitamin D3Drug
4000 IU of Vitamin D will be administered in capsule form, once daily.
| Study group | Role | What they receive |
|---|---|---|
| 1000 IU of Vitamin D Daily | Active comparator | Participants randomized to take a 1000 IU capsule of Vitamin D every day for 6 months. Receives: Drug: 1000 IU of Vitamin D3 |
| 4000 IU of Vitamin D Daily | Experimental | Participants randomized to take a 4000 IU capsule of Vitamin D capsule every day for 6 months. Receives: Drug: 4000 IU of Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adequate Vitamin D Level
Vitamin D sufficiency will be assessed as the percentage of participants with a vitamin D level >30 ng/ml.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startSep 2013
- Primary completion26 Sep 2014
- Study completion26 Sep 2014
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 DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Responsible party
- Principal investigator, Larry Greenbaum, MD, PhD, Emory University
- Investigators
- Larry Greenbaum, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909115
- Sponsor's protocol ID
- IRB00067067
- Other IDs
- EmoryPedNeph-001
- Status last verified
- May 2020
- First submitted
- 24 Jul 2013
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nadeem S, Tangpricha V, Ziegler TR, Rhodes JE, Leong T, Xiang Y, Greenbaum LA. Randomized trial of two maintenance doses of vitamin D in children with chronic kidney disease. Pediatr Nephrol. 2022 Feb;37(2):415-422. doi: 10.1007/s00467-021-05228-z. Epub 2021 Aug 15.
PubMed 34392411
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Two Maintenance Doses of Vitamin D and Trace Element Status in Children With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01909115
- Acronym / sponsor ID
- IRB00067067
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Study start
- Sep 2013 (actual)
- Primary completion
- 26 Sep 2014 (actual)
- Study completion
- 26 Sep 2014 (actual)
- First posted
- 26 Jul 2013 (estimated)
- 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.
Vitamin D deficiency is common in the general population and more common in children with chronic kidney disease. Vitamin D is very important for bone health, especially in children with chronic kidney disease. To date, several studies using different doses of vitamin D have been tried to correct vitamin D deficiency, but none has been completely successful. The investigators are comparing two different doses of vitamin D to determine which one is more effective at correcting and maintaining normal blood levels of vitamin D. The investigators hypothesize that a higher percentage of children receiving a higher dose of vitamin D will be vitamin D replete at the end of 6 months.
This study will enroll 80 children 9 to 18 years old who have chronic kidney disease (CKD) and can take pills. They will be enrolled from Chronic Renal Insufficiency Clinic, the Hemodialysis Unit, Peritoneal Dialysis Clinic and Transplant Clinic at Children's Healthcare of Atlanta.
Detailed description
Vitamin D has a critical role in bone metabolism. In addition, there is increasing evidence that vitamin D has an important role in many other areas, including cardiovascular health, immune function, and prevention of autoimmune diseases and certain malignancies. In patients with CKD, there are a variety of abnormalities in mineral metabolism that lead to bone disease.
After the investigators obtain informed consent and assent, children will be randomly assigned to either low dose (1000 units daily) or high dose (4000 units daily) vitamin D pills (50% in each group). Participants will take vitamin D capsules every day for for 6 months. Vitamin D levels will be obtained at baseline, 3 months and 6 months. The study visits will be at the same time as routine clinic visits when the children are having blood drawn for routine care. At the end of the study, the investigators will compare the percentage of patients who have normal vitamin D levels at 6 months in the two groups. The investigators will also describe the percentage of patients who have elevated or low levels of trace elements.
The two doses of vitamin D in this study are within the dosing range recommended by the Institute of Medicine, and thus the investigators do not anticipate any adverse effects. Vitamin D toxicity could theoretically occur, and an elevated vitamin D level at 3 months would be an indication to withdraw a patient from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1000 IU of Vitamin D Daily | Active comparator | Drug: 1000 IU of Vitamin D3Participants randomized to take a 1000 IU capsule of Vitamin D every day for 6 months. |
| 4000 IU of Vitamin D Daily | Experimental | Drug: 4000 IU of Vitamin D3Participants randomized to take a 4000 IU capsule of Vitamin D capsule every day for 6 months. |
Who may qualify
- Ages
- 9 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patient's parent/legal guardian must be willing and able to give written informed consent and the patient must be willing to give written informed assent if applicable
- Estimated glomerular filtration rate < 60 mL/min/1.73 m2 body surface area or recipient of a kidney transplant
- 9-21 years old
- Able to swallow pills
Key exclusion criteria (7 listed)
- Liver failure
- Malabsorption
- Current calcium level >10.5 mg/dL
- History of hypercalcemia (Ca >11 mg/dL) during the preceding 6 months
- Current treatment with an antiepileptic drug or other medications that may affect vitamin D metabolism (e.g., phenobarbital, phenytoin, rifampicin)
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 |
|---|---|---|
| 1000 IU of Vitamin D31000 IU of Vitamin D will be administered in capsule form, once daily. | Drug | 1000 IU of Vitamin D Daily |
| 4000 IU of Vitamin D34000 IU of Vitamin D will be administered in capsule form, once daily. | Drug | 4000 IU of Vitamin D Daily |
Primary outcome
Percentage of Participants with Adequate Vitamin D Level
Time frame: Month 6
Vitamin D sufficiency will be assessed as the percentage of participants with a vitamin D level >30 ng/ml.
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 19 May 2020.
- Derived from this study: PubMed 34392411Nadeem S, Tangpricha V, Ziegler TR, Rhodes JE, Leong T, Xiang Y, Greenbaum LA. Randomized trial of two maintenance doses of vitamin D in children with chronic kidney disease. Pediatr Nephrol. 2022 Feb;37(2):415-422. doi: 10.1007/s00467-021-05228-z. Epub 2021 Aug 15.
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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.
Larry Greenbaum, MD, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1000 IU of Vitamin D3 and 4000 IU of Vitamin D3 in people with Chronic Kidney Disease, run by Emory University at 1 site in United States.
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 4 inclusion and 7 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 19 May 2020. 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 United States. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Percentage of Participants with Adequate Vitamin D Level (time frame: Month 6). 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 NCT01909115, 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 19 May 2020.