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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02213614
Other study ID # vio829429989
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 5, 2014
Last updated June 22, 2015
Start date August 2014
Est. completion date August 2016

Study information

Verified date June 2015
Source American Society Of Thermalism And Climatology Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date August 2016
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 14 Years to 60 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Dietary Supplement:
Lithium Water
Supply daily doses of Lithium water in form bottled mineral water
placebo: spring mineral water
Drink spring natural water a placebo 3 times a day
Other:
natural spring water
A group will drink natural spring water for 4 months

Locations

Country Name City State
United States Gaviota Clinic Newark New Jersey

Sponsors (1)

Lead Sponsor Collaborator
American Society Of Thermalism And Climatology Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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