drugset / Trial / NCT04222816

Effect of Regulated Add -on Sodium Chloride Intake on Stabilization of Serum Lithium Concentration in Bipolar Disorder

NCT04222816

RandomizedParallel-groupSingle-blindPrevention

Summary

Bipolar affective disorder or manic -depressive psychosis (MDP) is a mood disorder affecting 2.4% of the global population . Lithium is considered as the "gold standard" for the treatment of bipolar disorder but the clinical use of lithium is often restricted due to its narrow therapeutic range and adverse effects. In a published case report, Bleiwiss H found that sodium chloride supplementation diminished the adverse effects caused by lithium The literature search also revealed that till date, there is no published clinical study evaluating the effect of dietary intake of sodium in preventing the fluctuations of serum lithium level and lithium toxicity Therefore, a randomized clinical trial has been designed to evaluate the effect of regulated add -on dietary sodium chloride on serum lithium levels in bipolar disorder.

Timeline

Start
2020-01-16
Primary completion
2021-12-31
Completion
2022-01-07

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject sodium chloride Unknown 1 g Oral
Background Lithium Carbonate Unknown 800 mg Oral
Background Lithium Carbonate Unknown 900 mg Oral

Indications