At a glance
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Effect of Regulated Add -on Sodium Chloride Intake on Stabilization of Serum Lithium Concentration in Bipolar Disorder: A Randomized Controlled Trial
In Brief
A Phase 4 clinical trial evaluating Lithium Carbonate and Sodium chloride for Bipolar Affective Disorder. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Lithium carbonate 800-900 mg orally daily for 12 weeks
Sodium chloride 1gm daily per orally for 12 weeks