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
  Purpose

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.


Condition Intervention Phase
Heart Diseases
Dietary Supplement: Folic Acid
Drug: Placebo Folic Acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Plasma homocysteine levels [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum folate levels [ Time Frame: Measured at Week 6 ] [ Designated as safety issue: No ]

Enrollment: 133
Study Start Date: June 1996
Study Completion Date: September 1996
Primary Completion Date: September 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Participants will receive placebo folic acid.
Drug: Placebo Folic Acid
Placebo folic acid once a day for 6 weeks
Experimental: 2
Participants will receive 100 mcg of folic acid.
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
Experimental: 3
Participants will receive 400 mcg of folic acid.
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
Experimental: 4
Participants will receive 1000 mcg of folic acid.
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
Experimental: 5
Participants will receive 2000 mcg of folic acid.
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

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807807

Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Lawrence J. Appel, MD, MPH Johns Hopkins University
  More Information

No publications provided

Responsible Party: Lawrence J. Appel, MD, MPH, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00807807     History of Changes
Other Study ID Numbers: 617, U01 HL050981, M01-RR00052
Study First Received: December 10, 2008
Last Updated: December 12, 2008
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Plasma Homocysteine Concentration
Folate
Homocysteine
Supplements
Folic Acid

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014