EpilepsyPhase 4NCT02890823
Effect of Three Different Doses of Oral Cholecalciferol on 25-Hydroxyvitamin D Changes Among Epilepsy Patients With Hypovitaminosis D
A Phase 4 study testing Cholecalciferol in people with Epilepsy, run by Chulalongkorn University.
Trial summary
To characterize the effect of three different doses of vitamin D3 supplementation on serum 25-hydroxyvitamin D (25(OH)D) changes in epilepsy patients receiving enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs), and to determine the prevalence of… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Mar 2016
- Phase
- Phase 4
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Epilepsy patients, age ≥ 15 years, BMI18 - 30 kg/m2
- Being treated with either enzyme inducing antiepileptic drugs (EIAEDs: phenytoin, phenobarbital, carbamazepine and topiramate) or non-enzyme inducing antiepileptic drugs (Non-EIAEDs: sodium valproate, levetiracetam, and lamotrigine) at a stable dosage regimen for at least a year.
- Serum 25(OH)D <30ng/ml
Who cannot join
- Patients with a history of hypercalcemia, nephrolithiasis, fractures, hepatic disease, kidney disease, granulomatous disease or currently supplemented with vitamin D.
About this study
Official title: EFFECT OF THREE DIFFERENT DOSES OF ORAL CHOLECALCIFEROL (1000 IU, 3000 IU AND 6000 IU DAILY) ON SERUM 25-HYDROXYVITAMIN D CHANGES AMONG EPILEPSY PATIENTS WITH HYPOVITAMINOSIS D: A RANDOMIZED PROSPECTIVE STUDY
To characterize the effect of three different doses of vitamin D3 supplementation on serum 25-hydroxyvitamin D (25(OH)D) changes in epilepsy patients receiving enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs), and to determine the prevalence of and risk factors for hypovitaminosis D among Thai patients with epilepsy.
Read the detailed description
A single-blinded prospective, randomized study undertaken at epilepsy clinic of King Chulalongkorn Memorial Hospital. The patients with hypovitaminosis D were included and divided into two groups according to the type of AEDs use. Patients receiving each AEDs type were randomly assigned to receive vitamin D3 1000, 3000 or 6000 IU once daily. The mean increment in serum 25(OH)D levels were measured at 8 and 16 weeks.
- Conditions
- Epilepsy
- Being tested
- Cholecalciferol
- Keywords
- Antiepileptic Drugs, Vitamin D Deficiency, Asian
- Medical subject headings
- Epilepsy, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
| Study group | Role | What they receive |
|---|---|---|
| EIAEDs-1000 | Experimental | Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily Receives: Drug: Cholecalciferol |
| EIAEDs-3000 | Experimental | Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily Receives: Drug: Cholecalciferol |
| EIAEDs-6000 | Experimental | Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily Receives: Drug: Cholecalciferol |
| non-EIAEDs-1000 | Active comparator | Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily Receives: Drug: Cholecalciferol |
| non-EIAEDs-3000 | Active comparator | Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily Receives: Drug: Cholecalciferol |
| non-EIAEDs-6000 | Active comparator | Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 25-hydroxyvitamin D changes in patients who received enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs) at the same dosage of cholecalciferal
Measured: 8 and 16 months
Secondary outcomes (1)
Number (percentage) of the patients who have serum 25-hydroxyvitamin D levels more than 30ng/ml
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Chulalongkorn 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890823
- Sponsor's protocol ID
- RA58/075
- Status last verified
- Sep 2016
- First submitted
- 1 Sep 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF THREE DIFFERENT DOSES OF ORAL CHOLECALCIFEROL (1000 IU, 3000 IU AND 6000 IU DAILY) ON SERUM 25-HYDROXYVITAMIN D CHANGES AMONG EPILEPSY PATIENTS WITH HYPOVITAMINOSIS D: A RANDOMIZED PROSPECTIVE STUDY
- ClinicalTrials.gov ID
- NCT02890823
- Acronym / sponsor ID
- RA58/075
- Conditions
- Epilepsy
- Keywords
- Antiepileptic Drugs, Vitamin D Deficiency, Asian
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Sep 2016 (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.
To characterize the effect of three different doses of vitamin D3 supplementation on serum 25-hydroxyvitamin D (25(OH)D) changes in epilepsy patients receiving enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs), and to determine the prevalence of and risk factors for hypovitaminosis D among Thai patients with epilepsy.
Detailed description
A single-blinded prospective, randomized study undertaken at epilepsy clinic of King Chulalongkorn Memorial Hospital. The patients with hypovitaminosis D were included and divided into two groups according to the type of AEDs use. Patients receiving each AEDs type were randomly assigned to receive vitamin D3 1000, 3000 or 6000 IU once daily. The mean increment in serum 25(OH)D levels were measured at 8 and 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| EIAEDs-1000 | Experimental | Drug: CholecalciferolPatients receiving EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily |
| EIAEDs-3000 | Experimental | Drug: CholecalciferolPatients receiving EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily |
| EIAEDs-6000 | Experimental | Drug: CholecalciferolPatients receiving EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily |
| non-EIAEDs-1000 | Active comparator | Drug: CholecalciferolPatients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily |
| non-EIAEDs-3000 | Active comparator | Drug: CholecalciferolPatients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily |
| non-EIAEDs-6000 | Active comparator | Drug: CholecalciferolPatients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Epilepsy patients, age ≥ 15 years, BMI18 - 30 kg/m2
- Being treated with either enzyme inducing antiepileptic drugs (EIAEDs: phenytoin, phenobarbital, carbamazepine and topiramate) or non-enzyme inducing antiepileptic drugs (Non-EIAEDs: sodium valproate, levetiracetam, and lamotrigine) at a stable dosage regimen for at least a year.
- Serum 25(OH)D <30ng/ml
Key exclusion criteria (1 listed)
- Patients with a history of hypercalcemia, nephrolithiasis, fractures, hepatic disease, kidney disease, granulomatous disease or currently supplemented with vitamin D.
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 |
|---|---|---|
| Cholecalciferol | Drug | EIAEDs-1000, EIAEDs-3000, EIAEDs-6000, non-EIAEDs-1000, non-EIAEDs-3000, non-EIAEDs-6000 |
Primary outcome
serum 25-hydroxyvitamin D changes in patients who received enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs) at the same dosage of cholecalciferal
Time frame: 8 and 16 months
1 secondary outcome
Number (percentage) of the patients who have serum 25-hydroxyvitamin D levels more than 30ng/ml
Time frame: 16 months
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 7 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cholecalciferol in people with Epilepsy, run by Chulalongkorn University.
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 3 inclusion and 1 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 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
serum 25-hydroxyvitamin D changes in patients who received enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs) at the same dosage of cholecalciferal (time frame: 8 and 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2016.