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Lithium Water in Gun Violence Prevention (LWGVP)

Primary Purpose

Assault by Handgun Discharge, Violence, Homicide

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lithium Water
placebo: spring mineral water
natural spring water
Sponsored by
American Society Of Thermalism And Climatology Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Assault by Handgun Discharge

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.

Sites / Locations

  • Gaviota Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Spring Lithium Water

Placebo: Natural Spring water

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 5, 2014
Last Updated
June 22, 2015
Sponsor
American Society Of Thermalism And Climatology Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02213614
Brief Title
Lithium Water in Gun Violence Prevention
Acronym
LWGVP
Official Title
Lithium Water Use in Gun Violence Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Society Of Thermalism And Climatology Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Lithium has a long history of use in the treatment of mental disorders. However, it hasn't been until recently that scientists began exploring the psychiatric implications of naturally occurring lithium in the water supply. As stated in the article, Foods Rich in Lithium And Lithium Supplements: "Research suggests that locations with the highest concentration of lithium tend to have the lowest rates of depression and violent crime. These studies have been conducted across the globe in different climates with different natural habits and diets. Researchers have therefore concluded that this phenomenon is fairly universal." A study in the United States agrees with these findings. According to Everything Addiction: "In a 1990 study of 27 Texas counties, researchers found an "inverse association of tap water lithium content in areas of Texas with the rates of mental hospital admissions, suicides, homicides, and certain other crimes." It was also discovered that young men incarcerated for violent crimes in some parts of Texas had disproportionately low lithium levels. Schrauzer and Shrestha discovered that the negative correlation was confirmed," especially in the south-central region of the state where high suicide mortality rates correspond to low lithium concentrations."' Another study published in the British Journal of Psychiatry had similar results. Researchers at Oita University examined the suicide rates in Japan's Oita prefecture. The team discovered that cities with higher levels of natural lithium in the public water supply had lower rates of suicide overall.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Assault by Handgun Discharge, Violence, Homicide, Sexual Assault by Bodily Force, Substance Abuse Problem

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spring Lithium Water
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo: Natural Spring water
Arm Type
Experimental
Arm Description
This group will be drink natural spring water for 4 months in tres cicles
Intervention Type
Dietary Supplement
Intervention Name(s)
Lithium Water
Other Intervention Name(s)
Spring mineral water, Crazy water
Intervention Description
Supply daily doses of Lithium water in form bottled mineral water
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo: spring mineral water
Other Intervention Name(s)
natural water, spring water
Intervention Description
Drink spring natural water a placebo 3 times a day
Intervention Type
Other
Intervention Name(s)
natural spring water
Other Intervention Name(s)
natural water, spring water
Intervention Description
A group will drink natural spring water for 4 months
Primary Outcome Measure Information:
Title
Change behavioral tendencies due to lithium water treatment
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garis Silega
Organizational Affiliation
American Society of Thermalism and Climatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Garis Silega, Doctor
Organizational Affiliation
American Society of Thermalism and Climatology
Official's Role
Study Director
Facility Information:
Facility Name
Gaviota Clinic
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States

12. IPD Sharing Statement

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Lithium Water in Gun Violence Prevention

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