NCT03371199

The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.

The Effect of Normalization of Sodium on Bone Markers in Patients With Epilepsy. A Randomized Single-blinded Placebo-controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hyponatremia
• Metabolic Bone Disease

Interventions

Type	Name	Description
DRUG	Sodium chloride	Sodium chloride tablets, 250 mg
DRUG	Placebo Oral Tablet	Starch tablets

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2017-12-13
• Last updated: 2019-03-28

Locations

1 site across 1 country: Denmark