Evaluating the Effects of Folic Acid Supplementation in Older Adults: The Folic Acid Supplementation Trial (The FAST Study)

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins University
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00807807
First received: December 10, 2008
Last updated: December 12, 2008
Last verified: December 2008

December 10, 2008
December 12, 2008
June 1996
September 1996   (final data collection date for primary outcome measure)
Plasma homocysteine levels [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00807807 on ClinicalTrials.gov Archive Site
Serum folate levels [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluating the Effects of Folic Acid Supplementation in Older Adults: The Folic Acid Supplementation Trial (The FAST Study)
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Heart Diseases
  • Dietary Supplement: Folic Acid
    100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks
    Other Name: Folate
  • Drug: Placebo Folic Acid
    Placebo folic acid once a day for 6 weeks
  • Placebo Comparator: 1
    Participants will receive placebo folic acid.
    Intervention: Drug: Placebo Folic Acid
  • Experimental: 2
    Participants will receive 100 mcg of folic acid.
    Intervention: Dietary Supplement: Folic Acid
  • Experimental: 3
    Participants will receive 400 mcg of folic acid.
    Intervention: Dietary Supplement: Folic Acid
  • Experimental: 4
    Participants will receive 1000 mcg of folic acid.
    Intervention: Dietary Supplement: Folic Acid
  • Experimental: 5
    Participants will receive 2000 mcg of folic acid.
    Intervention: Dietary Supplement: Folic Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
September 1996
September 1996   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy
  • Living in the Baltimore area

Exclusion Criteria:

  • 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)
Both
60 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00807807
617, U01 HL050981, M01-RR00052
No
Lawrence J. Appel, MD, MPH, Johns Hopkins University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
  • Johns Hopkins University
  • National Center for Research Resources (NCRR)
Principal Investigator: Lawrence J. Appel, MD, MPH Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP