The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.
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|ClinicalTrials.gov Identifier: NCT03371199|
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : March 28, 2019
The study investigates the association between normalization of serum sodium levels and bone markers in patients with epilepsy and chronic hyponatremia.
The study is a randomized, single blinded, placebo controlled study where participants will be randomized to either treatment with salt tablets or placebo tablets through 4 months. At the beginning and end of the 4 months bone markers will be measured.
The investigators null-hypothesis is that there will be no difference in bone markers before or after the intervention.
|Condition or disease||Intervention/treatment||Phase|
|Hyponatremia Metabolic Bone Disease||Drug: Sodium chloride Drug: Placebo Oral Tablet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of Normalization of Sodium on Bone Markers in Patients With Epilepsy. A Randomized Single-blinded Placebo-controlled Trial.|
|Actual Study Start Date :||December 1, 2017|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
Active Comparator: Sodium arm
Drug: Sodium chloride
Sodium chloride tablets, 250 mg
Placebo Comparator: Placebo arm
Drug: Placebo Oral Tablet
Other Name: Strarch tablets
- CTX1 change [ Time Frame: At baseline and after 4 months intervention ]bone markers
- P1NP change [ Time Frame: At baseline and after 4 months intervention ]Bone markers
- DXA scan change [ Time Frame: At baseline and after 4 months intervention ]Density measurements
- Cognitive function change [ Time Frame: At baseline and after 4 months intervention ]Epitrack test, scale from 9-49 (9 worst score - 49 best score)
- Life quality change [ Time Frame: At baseline and after 4 months intervention ]Quoli 31, scale from 0-100 (0 lowest life quality - 100 best life quality)
- Change in daily pains [ Time Frame: At baseline and after 4 months intervention ]VAS from 0-10 (0 no pains - 10 maximum pain)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371199
|Glostrup, Denmark, 2600|
|Study Chair:||Noémi B Andersen, DMSc, MD||Senoir consultant|