Heavy Metal Urine Analysis in 20 Healthy Persons Taking Mineralox

Healthy Clinical Trial

Official title:

Heavy Metal Urine Analysis in 20 Healthy Persons Taking Mineralox

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00623675
• Other study ID #: ZEO-002
• Status: Suspended
• Phase: Phase 4
• First received: February 17, 2008
• Last updated: July 6, 2009
• Start date: February 2008

Study information

• Verified date: July 2009
• Source: CreoMed, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Researchers want to find out if urine heavy metal levels are changed in persons who use Mineralox Basic C™ (Mineralox). Mineralox is a zeolite (clinoptilolite) in combination with Vitamin C. Zeolites are natural supplements (nutraceuticals) that work at the cellular level to remove heavy metals and toxins that are accumulated in every day life safely from the body through the urine. The study doctor will give Mineralox to 20 people in this study to see if it helps with the heavy metal removal from the body.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Females and Males age 18-75 without significant health problems as determined by the Principal Investigator.

2. Nonsmoker

3. Ability to understand informed consent

Exclusion Criteria:

1. Pregnancy

2. Any serious or unstable disease within 6 months; seizure risk; diabetes mellitus requiring insulin or oral hypoglycemic medication; diagnosis of eating disorder, use of MAOI in the prior 14 days; hepatic or renal impairment; clinically significant cardiovascular disease within 6 months; uncontrolled hypertension; severe chronic obstructive pulmonary disease; baseline systolic blood pressure higher than150mm Hg or diastolic blood pressure higher than 95 mm Hg; history of cancer (except treated basal cell or squamous cell carcinoma of the skin); history of clinically significant allergic reactions or laboratory abnormalities,and patients taking AREDS Eye Vitamins.

3. Major depressive disorder within the past year requiring treatment; history of panic disorder, psychosis, bipolar disorder, or eating disorder

4. Intention to donate blood or blood products during treatment phase of the study;

5. Alcohol or drug abuse/dependency within the past year

6. Use of tobacco products other than cigarettes or use of marijuana

7. Body mass index (calculated as weight in kilograms divided by the square height in meters) less than 15 or greater than 38 or weight less than 45.5 kg

8. NRT, antidepressants, antipsychotics, mood stabilizers/anticonvulsants, naltrexone, steroids or insulin.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Mineralox C
Mineralox C 2 capsules three times a day.

Locations

Country	Name	City	State
United States	NEMA Research	Naples	Florida

Sponsors (1)

Lead Sponsor	Collaborator
CreoMed, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heavy Metal Urine Analysis		3 months	Yes

External Links

•   Link