Phase 2 Reduction of Dietary Mycotoxin Exposure by ACCS100" (RDMEACCS100)
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Purpose
The primary purpose of the study is to evaluate the effectiveness of a naturally occurring clay substance (ACCS100) in reducing harmful effects of aflatoxin exposure (a carcinogen) and fumonisin (a cancer promoter). This clay substance contains of a variety of minerals including calcium, sodium, potassium, and magnesium. UPSN and similar aluminosilicate minerals have been regularly used as dietary supplements by humans and animals, and the safety of this naturally occurring clay substance has been tested in clinical trials. The FDA treats such minerals or nutritional supplements as a drug when tested for potential of lessening the likelihood of disease (i.e., potential for mitigating disease).
This study involves the use of an investigational drug called Hydrated Sodium Calcium Aluminosilicate (ACCS100). "Investigational" means that the "drug" has not yet been approved by the U.S. Food & Drug Administration (FDA) for reducing harmful effects mycotoxin exposure in humans.
| Condition | Intervention | Phase |
|---|---|---|
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Dietary Carcinogenesis |
Drug: ACCS100 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | A Phase 2 Study of the Reduction of Dietary Mycotoxin Exposure by ACCS100 |
- Reduction of dietary mycotoxin (Aflatoxin-AFB1 and Fumonisin-FB1) exposure in participants in Bexar County, Texas [ Time Frame: Two year study ] [ Designated as safety issue: No ]We hypothesize that ingesting ACCS100 prior to each meal (total of 1.5 or 3 g/day) will reduce the participant's exposure to AFB1 and FB1 as indicated by blood and urine levels of AFB1/FB1 metabolites. The ultimate purpose of this project will be to reveal the value of mineral enterosorbent strategies to reduce exposure to dietary mycotoxin risk factors for disease.
- Compare side-effects and adverse events between ACCS100 and placebo in the participant population [ Time Frame: 2 Year study ] [ Designated as safety issue: Yes ]The raw material from which ACCS100 is produced is generally recognized as safe (GRAS) by the FDA, is an approved food and feed additive, and is considered safe at up to 40 grams of a 2 kg/day diet. The maximum dose of ACCS100 for this study is 3.0 grams per day or less than one-tenth of the maximum level in food permitted by the FDA.
- • Determine the prevalence of mycotoxin exposure in the screened population of residence of Bexar County, Texas [ Time Frame: 2 Year Study ] [ Designated as safety issue: Yes ]Approximately 800 potential participants will be screened for blood or urine levels of aflatoxin and fumonisin. The results of this epidemiological and incidence survey is a part of the information that will be reported.
| Estimated Enrollment: | 225 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
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Active Comparator: ACCS100 High Dose
Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.
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Drug: ACCS100
ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article.
Other Names:
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Active Comparator: ACCS100 Low Dose
Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.
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Drug: ACCS100
ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article.
Other Names:
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Placebo Comparator: Placebo
Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.
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Drug: Placebo
Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article.
Other Name: Calcium Carbonate
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
3.1 Participant Inclusion Criteria 3.1.1 Detectable blood AFB1-albumin adduct levels (limit of detection=0.01 pmol/mg albumin) 3.1.2 18 -85 years 3.1.3 Ability to take oral capsules 3.1.4 Negative urine pregnancy test for women of childbearing age 3.1.5 Must have the ability to understand and the willingness to provide a written informed consent to participate in the study
Exclusion Criteria:
3.2 Participant Exclusion Criteria 3.2.1 History of known allergy to silicates 3.2.2 Pregnancy or lactation 3.2.3 History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up 3.2.4 Any serious systemic disorders incompatible with the study 3.2.5 History of chronic disease (ie heart disease, renal disease). A participant may have a diagnosis of and be managed for diabetes) Any recent diagnosis of cancer.
3.2.6 Participation in any other clinical study where the participant is actively taking an investigational medication within the last 30 days
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Contacts and Locations| Contact: Holly Hayes, MSPH | 210-567-0846 | hayesh@uthscsa.edu |
| Contact: Marisa F Rodriguez, BS | 210-567-0913 | rodriguezm21@uthscsa.edu |
| United States, Texas | |
| University of Texas Health Science Center Cancer Treatment Research Center | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Holly Hayes, MSPH 210-567-0846 hayesh@uthscsa.edu | |
| Contact: Marisa F Rodriguez, BS 210-567-0913 rodriguezm21@uthscsa.edu | |
| Principal Investigator: Fernando A Guerra, MD, MPH | |
| Principal Investigator: Bradley H. Pollock, MPH, Ph.D. | |
| Principal Investigator: | Bradley H Pollock, MPH, Ph.D. | University of Texas Health Science Center San Antonio Texas |
More Information
Publications:
| Responsible Party: | Texas Enterosorbents Incorporated |
| ClinicalTrials.gov Identifier: | NCT01677195 History of Changes |
| Other Study ID Numbers: | TxESI 12-001 |
| Study First Received: | August 29, 2012 |
| Last Updated: | September 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Texas Enterosorbents Incorporated:
|
Mycotoxins Aflatoxin Fumonisin |
Aflatoxicosis Dietary Cancer |
Additional relevant MeSH terms:
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Calcium Carbonate Antacids Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013