Heavy Metal Urine Analysis in 20 Healthy Persons Taking Mineralox

NCT ID: NCT00623675

Last Updated: 2009-07-07

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

Mineralox C

Intervention Type: DIETARY_SUPPLEMENT

Mineralox C 2 capsules three times a day.

Interventions

Mineralox C

Mineralox C 2 capsules three times a day.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CreoMed, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

NEMA Research, Inc

Principal Investigators

Joseph V Pergolizzi, MD

Role: PRINCIPAL_INVESTIGATOR

NEMA Research, Inc.

Locations

NEMA Research

Naples, Florida, United States

Countries

United States

Other Identifiers

ZEO-002

Identifier Type: -

Identifier Source: org_study_id