Heart DiseasesPhase 3FASTNCT00807807
Evaluating the Effects of Folic Acid Supplementation in Older Adults: The Folic Acid Supplementation Trial (The FAST Study)
A Phase 3 study testing Folic Acid in people with Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
High levels of homocysteine, which is an amino acid in the blood, have been linked to an increased risk of heart disease. This study will examine the effect that differing levels of folic acid have on reducing homocysteine levels among older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Folic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- Jun 1996to Sep 1996
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Living in the Baltimore area
Who cannot join
- Taking multivitamins or B-vitamins
- Unwilling to discontinue supplements for 8 weeks before study entry
- Use of intramuscular vitamin B12
- Seizure disorder
- Pernicious anemia
- Long-term use of anti-folate drugs (e.g., methotrexate, sulfa-antibiotics)
About this study
Official title: Phase III Study of the Effects of Folic Acid Supplementation on Serum Folate and Plasma Homocysteine in Older Adults: A Dose-Response Trial
High levels of homocysteine, which is an amino acid in the blood, have been linked to an increased risk of heart disease. This study will examine the effect that differing levels of folic acid have on reducing homocysteine levels among older adults.
Read the detailed description
Elevated levels of homocysteine may be a risk factor for coronary heart disease, stroke, and peripheral vascular disease. Folate is a type of B vitamin that occurs naturally in food. In nutritional supplements, folate is known as folic acid, and it has been shown to lower the concentration of homocysteine in blood. Folic acid supplements are a simple way for people to increase their folate intake, lower their homocysteine levels, and reduce their risk of developing heart disease. However, more research is required to determine the most effective dose of folic acid needed to lower homocysteine levels. The purpose of this study is to examine the effect that varying doses of folic acid have on folate levels and homocysteine concentration levels in older adults.
This 6-week study will enroll healthy adults over the age of 60 who do not currently take multivitamins or B-vitamins. At a screening visit, participants will complete questionnaires on medical history, demographics, and diet. Also, height and weight will be measured, and a blood collection will occur. At a baseline study visit, participants will be randomly assigned to receive either placebo or one of four doses of folic acid-100 mcg, 400 mcg, 1000 mcg, or 2000 mcg-to be taken once a day for 6 weeks. Participants will attend a final study visit at Week 6, at which time another blood collection will occur.
- Conditions
- Heart Diseases
- Being tested
- Folic Acid, Placebo Folic Acid
- Keywords
- Plasma Homocysteine Concentration, Folate, Homocysteine, Supplements, Folic Acid
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic AcidDietary supplement
Also called Folate
100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks
Placebo Folic AcidDrug
Placebo folic acid once a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Participants will receive placebo folic acid. Receives: Drug: Placebo Folic Acid |
| 2 | Experimental | Participants will receive 100 mcg of folic acid. Receives: Dietary Supplement: Folic Acid |
| 3 | Experimental | Participants will receive 400 mcg of folic acid. Receives: Dietary Supplement: Folic Acid |
| 4 | Experimental | Participants will receive 1000 mcg of folic acid. Receives: Dietary Supplement: Folic Acid |
| 5 | Experimental | Participants will receive 2000 mcg of folic acid. Receives: Dietary Supplement: Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma homocysteine levels
Measured: Measured at Week 6
Secondary outcomes (1)
Serum folate levels
Measured: Measured at Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2008 (estimated)
- Study startJun 1996
- Primary completionSep 1996
- Study completionSep 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Johns Hopkins University, National Center for Research Resources (NCRR)
- Investigators
- Lawrence J. Appel, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807807
- Sponsor's protocol ID
- 617
- Other IDs
- U01HL050981, M01RR000052
- Acronym
- FAST
- Status last verified
- Dec 2008
- First submitted
- 10 Dec 2008
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of the Effects of Folic Acid Supplementation on Serum Folate and Plasma Homocysteine in Older Adults: A Dose-Response Trial
- ClinicalTrials.gov ID
- NCT00807807
- Acronym / sponsor ID
- FAST / 617
- Conditions
- Heart Diseases
- Keywords
- Plasma Homocysteine Concentration, Folate, Homocysteine, Supplements, Folic Acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- Johns Hopkins University, National Center for Research Resources (NCRR)
- Study start
- Jun 1996
- Primary completion
- Sep 1996 (actual)
- Study completion
- Sep 1996 (actual)
- First posted
- 12 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High levels of homocysteine, which is an amino acid in the blood, have been linked to an increased risk of heart disease. This study will examine the effect that differing levels of folic acid have on reducing homocysteine levels among older adults.
Detailed description
Elevated levels of homocysteine may be a risk factor for coronary heart disease, stroke, and peripheral vascular disease. Folate is a type of B vitamin that occurs naturally in food. In nutritional supplements, folate is known as folic acid, and it has been shown to lower the concentration of homocysteine in blood. Folic acid supplements are a simple way for people to increase their folate intake, lower their homocysteine levels, and reduce their risk of developing heart disease. However, more research is required to determine the most effective dose of folic acid needed to lower homocysteine levels. The purpose of this study is to examine the effect that varying doses of folic acid have on folate levels and homocysteine concentration levels in older adults.
This 6-week study will enroll healthy adults over the age of 60 who do not currently take multivitamins or B-vitamins. At a screening visit, participants will complete questionnaires on medical history, demographics, and diet. Also, height and weight will be measured, and a blood collection will occur. At a baseline study visit, participants will be randomly assigned to receive either placebo or one of four doses of folic acid-100 mcg, 400 mcg, 1000 mcg, or 2000 mcg-to be taken once a day for 6 weeks. Participants will attend a final study visit at Week 6, at which time another blood collection will occur.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo Folic AcidParticipants will receive placebo folic acid. |
| 2 | Experimental | Dietary Supplement: Folic AcidParticipants will receive 100 mcg of folic acid. |
| 3 | Experimental | Dietary Supplement: Folic AcidParticipants will receive 400 mcg of folic acid. |
| 4 | Experimental | Dietary Supplement: Folic AcidParticipants will receive 1000 mcg of folic acid. |
| 5 | Experimental | Dietary Supplement: Folic AcidParticipants will receive 2000 mcg of folic acid. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy
- Living in the Baltimore area
Key exclusion criteria (6 listed)
- Taking multivitamins or B-vitamins
- Unwilling to discontinue supplements for 8 weeks before study entry
- Use of intramuscular vitamin B12
- Seizure disorder
- Pernicious anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic AcidAlso: Folate100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks | Dietary supplement | 2, 3, 4, 5 |
| Placebo Folic AcidPlacebo folic acid once a day for 6 weeks | Drug | 1 |
Primary outcome
Plasma homocysteine levels
Time frame: Measured at Week 6
1 secondary outcome
Serum folate levels
Time frame: Measured at Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence J. Appel, MD, MPH principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Folic Acid in people with Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma homocysteine levels (time frame: Measured at Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.