NCT02213614

Brief Summary

The word lithium frequently conjures images of catatonic psychiatric patients and side effects so severe that premature death is commonplace. But naturally occurring lithium is a far cry from pharmaceutical grades. Found in the soil, water and certain foods, it is an essential mineral for maintaining physical and mental health. When exposure is low, suicide rates, mental illness and violent crime increase

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

1.3 years

First QC Date

August 5, 2014

Last Update Submit

June 22, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change behavioral tendencies due to lithium water treatment

    During the next study we will analyze the behavior of violent tendencies in three counties of New Jersey (ESSEX, Hudson and Passaic) during the years 2010-2013, different parameters were identified such as: Firearms violence Domestic violence Killings Rape Theft Suicides Alcoholism Substance abuse We will Identify 400 individuals randomly with one or more of these known behaviors, which are invited to participate in the study, we will administer them a psycho-social test, a history clinical psycho-social study, levels of lithium in blood test and associated general tests, in addition to EEG, and neuro-physiological studies. 500 mcg will be given to one group which will indicate them a daily supplement of lithium water while the other group will only receive mineral spring water as a placebo.

    1 year

Study Arms (2)

Spring Lithium Water

EXPERIMENTAL

The Long term goal of this research project is the implementation of an effective, inexpensive therapy in communities with high risk of violence. Therapy will be based on a daily dietary supplement LIWA at appropriate doses. The short-term objective is to prove that Lithium water (LIWA) as a daily supplement is an intervention that prevents gun violence from occurring, and is a factor that decrease the violence for gun in our communities Gun violence poses a serious threat to America's children and youth. Existing data clearly point to the need for improved strategies for keeping guns out of the hands of children and youth and those who would harm them.

Dietary Supplement: Lithium Water

Placebo: Natural Spring water

EXPERIMENTAL

This group will be drink natural spring water for 4 months in tres cicles

Dietary Supplement: placebo: spring mineral waterOther: natural spring water

Interventions

Lithium WaterDIETARY_SUPPLEMENT

Supply daily doses of Lithium water in form bottled mineral water

Also known as: Spring mineral water, Crazy water
Spring Lithium Water

Drink spring natural water a placebo 3 times a day

Also known as: natural water, spring water
Placebo: Natural Spring water

A group will drink natural spring water for 4 months

Also known as: natural water, spring water
Placebo: Natural Spring water

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Men and women aged 14-60.
  • Existence of alcoholism, substance abuse, violence antecedent, suicide history Answered all questions in the pre-treatment safety questionnaire. Gave their oral and written consent to participate in the trial.

You may not qualify if:

  • Patients with renal failure, cardiovascular insufficiency, Addison's disease and untreated hypothyroidism.
  • Pregnancy. Patients who have vomiting or diarrhea or if fluid or salt (sodium) intake is increased or decreased.
  • Inadequate communication with examiner. Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.
  • Inability to sign a consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaviota Clinic

Newark, New Jersey, 07102, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Natural Childbirth

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ParturitionPregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Garis Silega

    American Society of Thermalism and Climatology

    PRINCIPAL INVESTIGATOR
  • Garis Silega, Doctor

    American Society of Thermalism and Climatology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 11, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2015

Study Completion

August 1, 2016

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations