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
  Purpose

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 Intervention Phase
Healthy
Dietary Supplement: Mineralox C
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Heavy Metal Urine Analysis in 20 Healthy Persons Taking Mineralox

Resource links provided by NLM:


Further study details as provided by CreoMed, Inc.:

Primary Outcome Measures:
  • Heavy Metal Urine Analysis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: February 2008
Arms Assigned Interventions
Experimental: A Dietary Supplement: Mineralox C
Mineralox C 2 capsules three times a day.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623675

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

Additional Information:
No publications provided

Responsible Party: Joseph Pergolizzi, Jr., MD, NEMA Research, Inc
ClinicalTrials.gov Identifier: NCT00623675     History of Changes
Other Study ID Numbers: ZEO-002
Study First Received: February 17, 2008
Last Updated: July 6, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014