Effect of Three Different Doses of Oral Cholecalciferol on 25-Hydroxyvitamin D Changes Among Epilepsy Patients With Hypovitaminosis D
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| ClinicalTrials.gov Identifier: NCT02890823 |
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Recruitment Status :
Completed
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
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Sponsor:
Chulalongkorn University
Information provided by (Responsible Party):
Chulalongkorn University
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Brief 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 and risk factors for hypovitaminosis D among Thai patients with epilepsy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy | Drug: Cholecalciferol | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 210 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | July 2015 |
| Actual Primary Completion Date : | March 2016 |
| Actual Study Completion Date : | March 2016 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Hereditary hypophosphatemic rickets
Pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Cholecalciferol
| Arm | Intervention/treatment |
|---|---|
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Experimental: EIAEDs-1000
Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily
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Drug: Cholecalciferol |
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Experimental: EIAEDs-3000
Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily
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Drug: Cholecalciferol |
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Experimental: EIAEDs-6000
Patients receiving EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily
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Drug: Cholecalciferol |
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Active Comparator: non-EIAEDs-1000
Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 1000 IU once daily
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Drug: Cholecalciferol |
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Active Comparator: non-EIAEDs-3000
Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 3000 IU once daily
|
Drug: Cholecalciferol |
|
Active Comparator: non-EIAEDs-6000
Patients receiving non-EIAEDs who were randomly assigned to receive vitamin D3 6000 IU once daily
|
Drug: Cholecalciferol |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- Number (percentage) of the patients who have serum 25-hydroxyvitamin D levels more than 30ng/ml [ Time Frame: 16 months ]
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| Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with a history of hypercalcemia, nephrolithiasis, fractures, hepatic disease, kidney disease, granulomatous disease or currently supplemented with vitamin D.
No Contacts or Locations Provided
| Responsible Party: | Chulalongkorn University |
| ClinicalTrials.gov Identifier: | NCT02890823 History of Changes |
| Other Study ID Numbers: |
RA58/075 |
| First Posted: | September 7, 2016 Key Record Dates |
| Last Update Posted: | September 7, 2016 |
| Last Verified: | September 2016 |
Keywords provided by Chulalongkorn University:
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Antiepileptic Drugs Vitamin D Deficiency Asian |
Additional relevant MeSH terms:
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Rickets Epilepsy Avitaminosis Vitamin D Deficiency Brain Diseases Central Nervous System Diseases Nervous System Diseases Deficiency Diseases Malnutrition Nutrition Disorders Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Metabolic Diseases Calcium Metabolism Disorders Vitamin D Cholecalciferol Hydroxycholecalciferols Calcifediol Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |