NCT00623675

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at P25-P50 for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
Last Updated

July 7, 2009

Status Verified

July 1, 2009

First QC Date

February 17, 2008

Last Update Submit

July 6, 2009

Conditions

Healthy

Keywords

zeolitesnutraceuticalsnatural supplementsHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Heavy Metal Urine Analysis

    3 months

Study Arms (1)

A

EXPERIMENTAL
Dietary Supplement: Mineralox C

Interventions

Mineralox CDIETARY_SUPPLEMENT

Mineralox C 2 capsules three times a day.

A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females and Males age 18-75 without significant health problems as determined by the Principal Investigator.
  • Nonsmoker
  • Ability to understand informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NEMA Research

Naples, Florida, 34108, United States

Location

Study Officials

  • Joseph V Pergolizzi, MD

    NEMA Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 17, 2008

First Posted

February 26, 2008

Study Start

February 1, 2008

Last Updated

July 7, 2009

Record last verified: 2009-07

Locations

US(1)