Heavy Metal Urine Analysis in 20 Healthy Persons Taking Mineralox
This study has suspended participant recruitment.
Sponsor:
CreoMed, Inc.
Information provided by:
CreoMed, Inc.
ClinicalTrials.gov Identifier:
NCT00623675
First received: February 17, 2008
Last updated: July 6, 2009
Last verified: July 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- Females and Males age 18-75 without significant health problems as determined by the Principal Investigator.
- Nonsmoker
- Ability to understand informed consent
Exclusion Criteria:
- Pregnancy
- 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.
- Major depressive disorder within the past year requiring treatment; history of panic disorder, psychosis, bipolar disorder, or eating disorder
- Intention to donate blood or blood products during treatment phase of the study;
- Alcohol or drug abuse/dependency within the past year
- Use of tobacco products other than cigarettes or use of marijuana
- 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
- NRT, antidepressants, antipsychotics, mood stabilizers/anticonvulsants, naltrexone, steroids or insulin.
Contacts and Locations
More Information
Additional Information:
Related Info 
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 May 22, 2013