Effect of Regulated Add -on Sodium Chloride Intake on Stabilization of Serum Lithium Concentration in Bipolar Disorder
Condition: Bipolar Affective Disorder
MeSH terms: Bipolar Disorder; Mood Disorders
Study type: Interventional
Phase: Phase 4

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.
    

Detailed 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.
    

Intervention name(s): Lithium Carbonate; Sodium chloride
Intervention type(s): Drug; Drug
Intervention description(s): Lithium carbonate 800-900 mg orally daily for 12 weeks; Sodium chloride 1gm daily per orally for 12 weeks
Intervention MeSH terms: Lithium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, open label, parallel group, active controlled clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Bipolar affective disorder; Lithium; Manic depressive psychosis; Sodium chloride