Air Pollution, Epigenetics and Cardiovascular Health: A Human Intervention Trial

Summary

In this study, the pills formulated are being used to try to ameliorate the effect of air pollution on epigenetic changes, specifically DNA methylation, potentially linked with particulate matter air pollution inhalation and cardiovascular health effects. The way in which this is achieved is that the vitamins, which act as methyl donors, add a methyl group to the DNA to reverse the loss observed on exposure to air pollution.

Specifically for this study, the methyl donor supplement has been made by Jamieson Laboratories, and consists of 50mg Vitamin B6 and 1 mg Vitamin B12, (both within Health Canada approved limits) and 2.5 mg folic acid. The non-vitamin ingredients are those commonly used in pill formation. However, the folic acid concentration is 2.5mg, which is above the 1.0mg limit set by Health Canada for a natural health product. This concentration, however, has been used in previous academic studies safely and effectively, and was also formulated by Jamieson Laboratories. (ClinicalTrials.gov number, NCT00106886; Current Controlled Trials number, ISRCTN14017017. HOPE2 study).

Conditions

• Heart Rate
• Heart Rate Variability
• Inflammation

Interventions

DRUG

methyl donor

The design will include a 2 week placebo run-in followed by a baseline blank study (2-hrs exposure to medical air) to provide benchmarks for all assessed variables. Participants will then receive a 4-week placebo treatment before the first PM2.5 exposure study. A 4-week methyl-donor treatment (Dose: 2.5 mg of folic acid, 50 mg of vitamin B6, and 1 mg of vitamin B12 once a day) will precede the 2nd PM2.5 exposure.

DRUG

Placebo

Placebo

Sponsors & Collaborators

• University of Toronto

  collaborator OTHER

• Unity Health Toronto

  collaborator OTHER

• Harvard School of Public Health (HSPH)

  lead OTHER

Principal Investigators

• Andrea Baccarelli, MD PHD MPH · HSPH

• Frances Silverman, PHD · Unity Health Toronto

• Diane R. Gold, MD · HSPH

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2014-07-31

Completion

2014-07-31

Countries

• Canada

Study Locations