Assault by Handgun DischargeLWGVPNCT02213614
Lithium Water in Gun Violence Prevention
A study testing Lithium Water and natural spring water in people with Assault by Handgun Discharge and Violence, run by American Society Of Thermalism And Climatology Inc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Assault by Handgun Discharge, Violence, Homicide
- What is being tested?
- Lithium Water and natural spring water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lithium Water Use in Gun Violence Prevention
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
Read the 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.
- Conditions
- Assault by Handgun Discharge, Violence, Homicide, Sexual Assault by Bodily Force, Substance Abuse Problem
- Being tested
- Lithium Water, placebo: spring mineral water, natural spring water
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium WaterDietary supplement
Also called Spring mineral water, Crazy water
Supply daily doses of Lithium water in form bottled mineral water
placebo: spring mineral waterDietary supplement
Also called natural water, spring water
Drink spring natural water a placebo 3 times a day
natural spring waterOther
Also called natural water, spring water
A group will drink natural spring water for 4 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Lithium Water |
| Placebo: Natural Spring water | Experimental | This group will be drink natural spring water for 4 months in tres cicles Receives: Dietary Supplement: placebo: spring mineral water; Other: natural spring water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2015 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assault by Handgun DischargeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Society Of Thermalism And Climatology Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Garis Silega, Principal investigator, American Society of Thermalism and ClimatologyGaris Silega, Doctor, Study director, American Society of Thermalism and Climatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213614
- Sponsor's protocol ID
- vio829429989
- Acronym
- LWGVP
- Status last verified
- Jun 2015
- First submitted
- 5 Aug 2014
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lithium Water Use in Gun Violence Prevention
- ClinicalTrials.gov ID
- NCT02213614
- Acronym / sponsor ID
- LWGVP / vio829429989
- Conditions
- Assault by Handgun Discharge, Violence, Homicide, Sexual Assault by Bodily Force, Substance Abuse Problem
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- American Society Of Thermalism And Climatology IncUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 11 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spring Lithium Water | Experimental | Dietary Supplement: Lithium WaterThe 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. |
| Placebo: Natural Spring water | Experimental | Dietary Supplement: placebo: spring mineral water, Other: natural spring waterThis group will be drink natural spring water for 4 months in tres cicles |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lithium WaterAlso: Spring mineral water, Crazy waterSupply daily doses of Lithium water in form bottled mineral water | Dietary supplement | Spring Lithium Water |
| placebo: spring mineral waterAlso: natural water, spring waterDrink spring natural water a placebo 3 times a day | Dietary supplement | Placebo: Natural Spring water |
| natural spring waterAlso: natural water, spring waterA group will drink natural spring water for 4 months | Other | Placebo: Natural Spring water |
Primary outcome
Change behavioral tendencies due to lithium water treatment
Time frame: 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garis Silega principal investigator
American Society of Thermalism and Climatology
Garis Silega, Doctor study director
American Society of Thermalism and Climatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lithium Water and natural spring water in people with Assault by Handgun Discharge and Violence, run by American Society Of Thermalism And Climatology Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change behavioral tendencies due to lithium water treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.