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

Bipolar Affective Disorder Clinical Trial

Official title:
Effect of Regulated Add -on Sodium Chloride Intake on Stabilization of Serum Lithium Concentration in Bipolar Disorder: A Randomized Controlled Trial

Clinical Trial 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.

Clinical Trial Description

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.One of the major adverse effects of lithium is nephrogenic diabetes insipidus which is due to long -term renal dysfunction. In the initial months of lithium therapy, psychiatrists face difficulty in titrating the dose and stabilizing serum lithium level and this fluctuation of serum lithium level may be due to a lithium-induced sodium depleted state. In a published case report, Bleiwiss H found that sodium chloride supplementation diminished the adverse effects caused by lithium. 8 In another case report, Tomita et al demonstrated that the change in sodium chloride intake can bring about changes in serum lithium and help in stabilizing the levels of serum lithium concentration. As all the case reports are from abroad, the effect of dietary sodium on serum lithium level among Indian population is completely unknown. 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. This study may help to explore the role of add -on sodium chloride in decreasing the fluctuations in the serum lithium level and improving the clinical outcome of patients with bipolar disorders. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04222816
Study type Interventional
Source All India Institute of Medical Sciences, Bhubaneswar
Contact
Status Completed
Phase Phase 4
Start date January 16, 2020
Completion date January 7, 2022
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