CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Sodium chloride +1 moredrug
Likely dose
Sodium chloride 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03371199
NCT03371199N/ACompleted
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The Effect of Normalization of Sodium on Bone Markers in Patients With Epilepsy. A Randomized Single-blinded Placebo-controlled Trial.

Rigshospitalet, Denmark·interventional·Posted Dec 13, 2017·Updated Mar 28, 2019

In Brief

A clinical study evaluating Sodium chloride and Placebo Oral Tablet for Hyponatremia and Metabolic Bone Disease. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyponatremia, Metabolic Bone Disease
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 13, 2017
Enrollment StartDec 1, 2017
Primary CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.6 years ago

Interventions

Sodium chloridedrug

Sodium chloride tablets, 250 mg

Placebo Oral Tabletdrug

Starch tablets