Heavy Metal Urine Analysis in 20 Healthy Persons Taking Mineralox

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00623675
Recruitment Status : Suspended
First Posted : February 26, 2008
Last Update Posted : July 7, 2009
Information provided by:
CreoMed, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Mineralox C Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Heavy Metal Urine Analysis in 20 Healthy Persons Taking Mineralox
Study Start Date : February 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A Dietary Supplement: Mineralox C
Mineralox C 2 capsules three times a day.

Primary Outcome Measures :
  1. Heavy Metal Urine Analysis [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00623675

United States, Florida
NEMA Research
Naples, Florida, United States, 34108
Sponsors and Collaborators
CreoMed, Inc.
Principal Investigator: Joseph V Pergolizzi, MD NEMA Research, Inc.

Additional Information:
Responsible Party: Joseph Pergolizzi, Jr., MD, NEMA Research, Inc Identifier: NCT00623675     History of Changes
Other Study ID Numbers: ZEO-002
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: July 7, 2009
Last Verified: July 2009

Keywords provided by CreoMed, Inc.:
natural supplements
Healthy volunteers