Skip to content

Plasma homocysteine response to folic acid intervention

A dose finding trial in ischaemic heart disease patients and healthy controls to determine whether chronic exposure to low-dose folic acid can lower homocysteine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN45296887
Enrollment
200
Registered
2008-03-05
Start date
2001-03-31
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischaemic heart disease Circulatory System Ischaemic heart disease

Interventions

In both IHD and healthy control groups, participants were stratified into tertiles of homocysteine concentration (from the screening blood sample). Subjects in each stratum were then randomised to rec

Sponsors

University of Ulster (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male and female, any age 2. IHD Patients: 2.1. Proven myocardial infarction more than three months previously 2.2. IHD on coronary angiography 2.3. A clinical diagnosis of angina confirmed by electrocardiogram (ECG) 3. Control subjects: healthy subjects age- and sex-matched with the IHD group from the local community

Exclusion criteria

Exclusion criteria: 1. IHD patients: 1.1. History of diabetes 1.2. Hepatic or renal disease 1.3. Haematological disorders 1.4. Use of B-vitamin supplements or use of medication known to interfere with folate metabolism 2. Healthy controls in addition had no history of CVD

Design outcomes

Primary

MeasureTime frame
Plasma homocysteine, measured at baseline, 6 weeks and 12 weeks in a subset, and at 26 weeks.

Secondary

MeasureTime frame
1. Serum folate, measured at baseline and at 26 weeks 2. Erythrocyte glutathione reductase activity coefficient (EGRac): an indicator of riboflavin status), measured at baseline 2. Plasma pyridoxal phosphate: an indicator of vitamin B6 status, measured at baseline 3. Serum vitamin B12, measured at baseline

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026