Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to see the effect of vitamin D3 supplementation on cardiac autonomic nerve function in male epileptic patients with hypovitaminosis D that weather vitamin D improves heart rate variability or not. The main questions it aims to answer are:
It is a self control trial. Participants will:
b) visit the university after 8 weeks for post interventional HRV testing . Researcher will compare the pre test and post test value of HRV testing.
In epilepsy, there is a shifting of autonomic balance toward sympathetic dominance & heart rate variability (HRV) is reduced which can be detected by interictal heart rate variability (HRV) testing. Patients treated with anti-epileptic drugs (AEDs) are suffered from one of its major adverse effects of vitamin D3 deficiency or hypovitaminosis D due to enzyme inducing effect of AEDs. Vitamin D3 is a neuroprotective hormone that modulates autonomic balance and regulates sympathetic and parasympathetic nervous systems. Vitamin D3 deficiency is also associated with the risk of reduced HRV. Administration of vitamin D3 in vitamin D3 deficient epileptic patients may improve their cardiac autonomic nerve function that can be interpreted by HRV.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 male epileptic patients with hypovitaminosis D | Experimental | 15 male epileptic patients with hypovitaminosis D will be enrolled. They will be supplemented with Vitamin D orally 50,000 IU/week for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | 15 male epileptic patients with hypovitaminosis D will be enrolled. They will be supplemented with Vitamin D orally 50,000 IU/week for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D3 supplementation has effects on cardiac autonomic nerve function in male epileptic patients with hypovitaminosis D. | In epilepsy, cardiac autonomic nerve function is altered which can be measured by heart rate variability test(HRV). HRV is reduced in epilepsy. Vitamin D3 supplementation in patients with epilepsy will improve their cardiac autonomic nerve function which can be detected by measuring various parameters of HRV test such as SDRR, LF(Low frequency). | 8 weeks |
Not provided
Not provided
Inclusion Criteria:
• Diagnosed male patients with Epilepsy by neurologist from the OPD of Department of Neurology by taking proper history of at least two unprovoked (or reflex) seizures occuring > 24 hours apart, from patients and eye witnesses.
Having hypovitaminosis D (serum vitamin D3 level <30 ng/ml)
Age: 20-40 years.
Exclusion Criteria:
• Epileptic patients taking Sodium valproate, oxcarbazepine, Topiramate, Lamotrigine, Levetiracetam.
Patient having absence seizure
Alcoholic
Smoker
Patients taking following drugs will be excluded-
Patients having known hypersensitivity to vitamin D3
All patients with the history of or currently suffering from following diseases & condition will be excluded-
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Registrar, BMU | Contact | +88 02 55165708 | 94 | registrar@bsmmu.edu.bd |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Samikha Sarker, MBBS, MD Resident (Phase B) | BMU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangladesh Medical University | Recruiting | Dhaka | Shahbag | 1000 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25060996 | Background | Teagarden DL, Meador KJ, Loring DW. Low vitamin D levels are common in patients with epilepsy. Epilepsy Res. 2014 Oct;108(8):1352-6. doi: 10.1016/j.eplepsyres.2014.06.008. Epub 2014 Jul 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001361 | Avitaminosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
15 epileptic patients with hypovitaminosis D will be enrolled
Not provided
Not provided
Not provided
Not provided
| D003677 |
| Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |