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Micronutrients as Adjunctive Treatment for Bipolar Disorder

NCT03541031 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-07-13

No results posted yet for this study

Summary

The purpose of the trial is to determine whether a 36-ingredient Micronutrient supplement (primarily vitamins and minerals) and Fish oil (omega-3 fatty acid) supplement improves nutritional status and allows lower doses of conventional medications to be effective for bipolar disorder with fewer side effects, when studied under randomized and fully blinded conditions and compared to a placebo. All participants must live in the vicinity of Bangor, Maine.

Conditions

Interventions

DIETARY_SUPPLEMENT

Micronutrient & Fish oil

Capsule containing a 36-ingredient micronutrient formula (EMPowerplus™) which has been widely researched for its usefulness in several psychiatric conditions. The second product is a capsule containing Fish oil (Wiley's Finest™ Wild Alaskan Fish Oil Peak EPA; 700 mg EPA plus DHA per capsule).

DIETARY_SUPPLEMENT

Olive oil & Safflower oil

Olive oil capsule manufactured to mimic Micronutrient and safflower oil capsule manufactured to mimic Fish oil

Sponsors & Collaborators

  • Eastern Maine Medical Center

    lead OTHER

Principal Investigators

  • Lewis Mehl-Madrona, MD, PhD · Eastern Maine Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2019-04-30
Completion
2019-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03541031 on ClinicalTrials.gov