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

January 24, 2022 updated by: RITUPARNA MAITI, All India Institute of Medical Sciences, Bhubaneswar

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Orissa
      • Khorda, Orissa, India, 751019
        • AIIMS Bhubaneswar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18 -60 years, of either sex with the clinical diagnosis of bipolar disorder (DSM V) who are on maintenance lithium therapy for ≥ 1month and ≤ 6 months.
  • Patients with normal serum sodium level (135 -145 mEq/L) and serum lithium in the optimum therapeutic range (<0.6 mEq/ L or >0.8 mEq/ L) .

Exclusion Criteria:

  • Patients with comorbidities like other psychiatric disorder s, organicity, substance abuse, personality disorder, intellectual disability and other neurotic disorders .
  • Patients with any renal, cardiovascular, neurologica l, endocrinal and hepatic dysfunction.
  • Patients suffering from diarrhoea, dehydration
  • History of any invasive neurosurgical/ non -invasive neuropsychiatric procedure.
  • Medication history of psychoactive or central nervous system depressant drugs.
  • Patients who are on NSAIDs, ACE inhibitors, antiarrhythmics, diuretics and neuromuscular blocking agents .
  • Pregnant and nursing women .
  • Patients with drug/alcohol abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lithium carbonate
Lithium carbonate is prescribed 800-900 mg per day for 12 weeks.
Drug: Lithium Carbonate
Lithium carbonate 800-900 mg orally daily for 12 weeks
Experimental: Add-on Sodium chloride
Sodium chloride 1gm per day per will be prescribed along with Lithium carbonate 800-900 mg per day for 12 weeks.
Drug: Lithium Carbonate
Lithium carbonate 800-900 mg orally daily for 12 weeks
Drug: Sodium chloride
Sodium chloride 1gm daily per orally for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in percentage of bipolar patients showing fluctuation in serum lithium level
Time Frame: 12 weeks
Serum lithium level will be done by electrolyte analyzer. The patients showing fluctuations ( fluctuation is defined as serum lithium <0.6 mEq/ L or >0.8 mEq/ L in maintenance phase) in serum lithium level between the groups over 12 weeks.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum sodium
Time Frame: 12 weeks
Will be done by electrolyte analyzer.
12 weeks
Serum Potassium
Time Frame: 12 weeks
Will be done by electrolyte analyzer.
12 weeks
Serum creatinine
Time Frame: 12 weeks
Will be done by autoanalyser.
12 weeks
Serum aldosterone
Time Frame: 12 weeks
Will be done by commercially available ELISA kit.
12 weeks
ECG changes
Time Frame: 12 weeks
ECG changes for lithium toxicity (T wave inversion, PR prolongation, QT prolongation), hyponatremia (P wave alterations), hypernatremia (short PR interval and diffuse ST depression) will be looked for
12 weeks
Serum Lithium
Time Frame: 12 weeks
Will be done by electrolyte analyzer.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Investigators

  • Study Director: DEBASISH HOTA, DM, Professor and Head of the department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

January 7, 2022

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 7, 2020

First Posted (Actual)

January 10, 2020

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 24, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEC/AIIMS BBSR/PG Th/19-20/76

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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