Overview

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

Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
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
Criteria
Inclusion Criteria:

- Healthy volunteer

- Age 18-60 years old

- Non-smoker

- must be able to fast 8 hours prior to exposure visits and for a further 4 hours during
the exposure

Exclusion Criteria:

- Subjects must not be regularly taking multivitamins, vitamins C & E, folate,
medications, fish oil or aspirin, oral or inhaled steroids, for 4 weeks before and
during the trial.

- Lipid abnormalities

- Asthma or respiratory disease

- Hypertension (Bp> 140/90) or taking any blood pressure drug

- Known cardiac disease

- abnormal homocysteine or glucose levels