Effect of Genetic Differences on Levels of Water Disinfection Byproducts in Blood After Showering

NCT00340535 | Completed

• 2 other identifiers: 99990422804-C-N228
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine whether genetic differences among individuals affect blood levels of certain chemicals called DBPs after showering. Chemicals such as chlorine and ozone are used to kill germs in water. These chemicals may react with organic matter in the water and form other chemicals called disinfection byproducts, or DBPs. Although people are usually exposed to DBPs by drinking tap water, these chemicals may also penetrate the body during showering. This study will see whether the levels of DBPs after showering vary among individuals depending on differences in genes that code for enzymes called GSTT1, CYP2D6, and CYP2E1, which break down DBPs. This study, sponsored by the Centers for Disease Control and Prevention and the National Institutes of Health, is conducted at the University of Pittsburgh's Center for Clinical Pharmacology. Healthy adults between 18 and 45 years of age who do not smoke cigarettes and are not taking any medicines may be eligible for this study. Candidates are screened with a medical history and blood and urine tests. Participants are given a diary to record the foods they eat and how much water they drink during the 2 days before their study appointment. The following activities are scheduled on the appointment day:

• Measurements of blood pressure, height, and weight, and pregnancy test for women
• Questions about alcohol consumed and medications taken in the last 48 hours
• Review of food and water diary
• Interview for demographic information (name, address, date of birth, etc.) and other information, such as sex, height, weight. Subjects are also asked about anything, such as exercise, that might affect their breathing, since breathing problems are a rare side effect of chlorzoxazone, a drug used in this study.
• Urine sample collection
• Blood draw and insertion of a small catheter (plastic tube) to allow for additional blood draws during the test procedure without having repeated needle sticks
• 10-minute shower in a private bathroom
• Blood sample collection 10 minutes after the shower and again at 30 minutes after the shower
• Dose of chlorzoxazone (a drug used to treat muscle pain)
• Interview about subject's exposure to water
• Light breakfast
• Blood and urine collections 2 hours after the chlorzoxazone dose
• Lunch
• Observation for drug side effects for 2 hours, or longer if needed Seven blood samples totaling 75 milliliters (about 5 tablespoonfuls) of blood are collected during this study. The blood is tested for chemicals called trihalomethanes to see how they are broken down. The urine samples are tested for chemicals called haloacetic acids, which are found in tap water after it has been treated with chlorine.

Conditions

Normal Physiology

Keywords

Disinfection byproducts; Genetic Variation; Trihalomethanes

Outcome Measures

Primary Outcomes (1)

• Blood trihalomethane levels

  Levels of triahlomethane levels in the blood

  Before and after showering

Study Arms (1)

Individuals

Individuals recruited at U of Pittsburgh

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

convenience sample of individuals recruited at the University of Pittsburgh.

You may qualify if:

• The study population will be comprised of non-smoking males and females in the age range 18-45 years. The age range was selected to limit variability in activity of important enzyme systems.
• Persons with lung conditions will be excluded because inhalation is a major route of exposure for trihalomethanes.
• Liver conditions will be excluded because of the potential risks possibly associated with chlorzoxazone administration.
• Pregnant and lactating women will be excluded from participation in the study, for multiple reasons, the major one being possible (but unknown) adverse health risks from chlorzoxazone exposure.
• In addition, we will exclude persons with chronic conditions such as diabetes who chronically use medication, such as Orinase or others. These persons will be excluded due to unknown effects of such disease on the enzyme systems under investigation and to avoid any possible adverse effects of the study, including chlorzoxazone administration.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (3)

• Boorman GA. Drinking water disinfection byproducts: review and approach to toxicity evaluation. Environ Health Perspect. 1999 Feb;107 Suppl 1(Suppl 1):207-17. doi: 10.1289/ehp.99107s1207.

  PMID: 10229719 BACKGROUND

• Cantor KP, Hoover R, Hartge P, Mason TJ, Silverman DT, Altman R, Austin DF, Child MA, Key CR, Marrett LD, et al. Bladder cancer, drinking water source, and tap water consumption: a case-control study. J Natl Cancer Inst. 1987 Dec;79(6):1269-79.

  PMID: 3480378 BACKGROUND

• McGeehin MA, Reif JS, Becher JC, Mangione EJ. Case-control study of bladder cancer and water disinfection methods in Colorado. Am J Epidemiol. 1993 Oct 1;138(7):492-501. doi: 10.1093/oxfordjournals.aje.a116883.

  PMID: 8213753 BACKGROUND

Study Officials

• Laura Beane-Freeman, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: June 23, 2004
• Primary Completion: October 1, 2004
• Study Completion: March 4, 2021
• Last Updated: March 5, 2021

Record last verified: 2021-03

Locations

US (1)