Heavy Metal Urine Analysis in 20 Healthy Persons Taking Mineralox

This study has suspended participant recruitment.
Sponsor:
Information provided by:
CreoMed, Inc.
ClinicalTrials.gov Identifier:
NCT00623675
First received: February 17, 2008
Last updated: July 6, 2009
Last verified: July 2009

February 17, 2008
July 6, 2009
February 2008
Not Provided
Heavy Metal Urine Analysis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00623675 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Heavy Metal Urine Analysis in 20 Healthy Persons Taking Mineralox
Heavy Metal Urine Analysis in 20 Healthy Persons Taking Mineralox

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Dietary Supplement: Mineralox C
Mineralox C 2 capsules three times a day.
Experimental: A
Intervention: Dietary Supplement: Mineralox C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
20
Not Provided
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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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00623675
ZEO-002
No
Joseph Pergolizzi, Jr., MD, NEMA Research, Inc
CreoMed, Inc.
Not Provided
Principal Investigator: Joseph V Pergolizzi, MD NEMA Research, Inc.
CreoMed, Inc.
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP