Recruiting

Micronutrients

Sponsor:

Eastern Maine Medical Center

Code:

NCT03541031

Conditions

Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Micronutrient & Fish oil

Olive oil & Safflower oil

Study Details

Brief 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

Bipolar Disorder

Study ID

NCT03541031

Start date

May 29, 2018

Status verified date

Jul, 2018

Completion date

Jun 30, 2019

Anticipated

Primary completion date

Apr 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Individuals enrolled will be adult outpatients with a diagnosis of bipolar disorder I or II, receiving care at the Family Medicine Center \& Residency Program of Eastern Maine Medical Center in Bangor, Maine. Participants must be able to complete questionnaires and examinations and comply with protocols.

Exclusion Criteria:

Participants will be excluded from the study for any of the following reasons:

1. Evidence of untreated or unstable thyroid disease (until it is treated and stabilized).
2. Known abnormality of mineral metabolism (e.g., Wilson's disease) until stabilized.
3. Unable to speak English
4. Any hypervitaminosis syndrome
5. Acute suicidality (until stabilized).

Participation in the study will not alter the participants' clinical care except that they will be provided Micronutrients and Fish oil (or placebos for each) and will participate in a monthly evaluation of the effect of adding these Micronutrients. We will ask them what other supplements they are taking and will instruct them not to take supplements that contain any of the same ingredients that they will receive in the study so as to avoid exceeding the maximum dose allowed.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Micronutrient & Fish oil

Fish oil capsule by mouth 3 capsules daily, remaining constant throughout the study and Micronutrient capsule by mouth beginning with a fixed schedule of 2 capsules twice daily and increasing monthly by 2 capsules twice daily up to a maximum of 16 capsules/day.

placebo comparator: Olive oil & Safflower oil

Safflower oil capsule by mouth 3 capsules daily, remaining constant throughout the study and Olive oil capsule by mouth beginning with a fixed schedule of 2 capsules twice daily and increasing monthly by 2 capsules twice daily up to a maximum of 16 capsules/day.

Interventions

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).

Olive oil & Safflower oil

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

Primary outcome measure

  • Changes in Side Effects [ Time Frame: Baseline and every month for 1 year ]

Central Contacts and Locations

Central contacts

Denise Michaud, BS

207-973-7175dmichaud@emhs.org

Janet Bayleran, PhD

207-973-7352jbayleran@emhs.org

Locations

Eastern Maine Medical Center

Recruiting

Bangor, Maine, United States, 04401

Contacts

Barbara Sorondo, MD, MD

207-973-4768bsorondo@emhs.org

Wendy Currier, BS

207-973-9033wcurrier@emhs.org

Principal Investigator:

Lewis Mehl-Madrona, MD, PhD

More Information

Sponsor

Eastern Maine Medical Center

Last update posted

Jul 13, 2018

Last verified

Jul, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Eastern Maine Medical Center on 2018-07-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.