Air Pollution, Epigenetics and Cardiovascular Health: A Human Intervention Trial
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 1
Details
Lead Sponsor:
Harvard School of Public Health Harvard School of Public Health (HSPH)
Collaborators:
St. Michael's Hospital, Toronto Unity Health Toronto University of Toronto
Treatments:
Folic Acid Hydroxocobalamin Pyridoxal Pyridoxine Vitamin B 12 Vitamin B 6 Vitamin B Complex Vitamins