The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.
NCT03371199 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2019-03-28
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
- DRUG
-
Sodium chloride
Sodium chloride tablets, 250 mg
- DRUG
-
Placebo Oral Tablet
Starch tablets
Sponsors & Collaborators
-
Rigshospitalet, Denmark
lead OTHER
Principal Investigators
-
Noémi B Andersen, DMSc, MD · Senoir consultant
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-01
- Primary Completion
- 2018-12-31
- Completion
- 2018-12-31
Countries
- Denmark
Study Locations
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