Plasma homocysteine response to folic acid intervention
| ISRCTN | ISRCTN45296887 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45296887 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/01/2008
- Registration date
- 05/03/2008
- Last edited
- 02/02/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mary Ward
Scientific
Scientific
Northern Ireland Centre for Food and Health
School of Biomedical Sciences
University of Ulster
Coleraine
BT521SA
United Kingdom
| Phone | +44 (0)28 7032 3076 |
|---|---|
| mw.ward@ulster.ac.uk |
Study information
| Study design | Double-blinded, randomised, placebo controlled dose finding trial with folic acid |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study objectives | Low dose folic acid (0.2 mg/d) administered chronically will significantly lower plasma homocysteine in ischaemic heart disease (IHD) patients and healthy age-sex matched controls. Previous studies may have overestimated the folic acid dose required to lower homocysteine because of too-short an intervention period to observe the full extent of the response to low folic acid doses and concluded that much higher doses were required for maximal homocysteine-lowering. If the hypothesis is confirmed the findings will have important implications for governments worldwide currently considering food fortification with folic acid, which although primarily aimed at reducing neural tube defects (NTDs), is expected to have important benefits in terms of the primary and secondary prevention of cardiovascular disease (CVD) via a homocysteine-lowering effect. |
| Ethics approval(s) | The study was approved by the University of Ulster Ethics committee in March 2000 (ref: 01/17). |
| Health condition(s) or problem(s) studied | Ischaemic heart disease |
| Intervention | 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 receive placebo, 0.2, 0.4 or 0.8 mg/d folic acid for a total intervention period of 26 weeks. To maximise compliance, vitamins were distributed every three weeks to the participants homes in seven-day pillboxes. The pillboxes were then collected and any unused pills recorded in order to monitor compliance. Total intervention period of 26 weeks for all treatment arms. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Folic acid |
| Primary outcome measure | Plasma homocysteine, measured at baseline, 6 weeks and 12 weeks in a subset, and at 26 weeks. |
| Secondary outcome measures | 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 |
| Overall study start date | 31/03/2001 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | n = 200 (100 patients, 100 controls) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 31/03/2001 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Northern Ireland Centre for Food and Health
Coleraine
BT521SA
United Kingdom
BT521SA
United Kingdom
Sponsor information
University of Ulster (UK)
University/education
University/education
c/o Mary Ward
School of Biomedical Sciences
Cromore Road
Coleraine
BT52 1SA
Northern Ireland
United Kingdom
| Phone | +44 (0)28 7032 3076 |
|---|---|
| mw.ward@ulster.ac.uk | |
| Website | http://www.ulster.ac.uk/ |
"ROR" |
https://ror.org/01yp9g959 |
Funders
Funder type
Charity
Northern Ireland Chest Heart and Stroke Association (UK)
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- NICHS
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2011 | Yes | No |
