NCT00807807

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 1996

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1996

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 1996

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1996

Completed
12.3 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2008

Completed
Last Updated

July 29, 2016

Status Verified

December 1, 2008

Enrollment Period

3 months

First QC Date

December 10, 2008

Last Update Submit

July 28, 2016

Conditions

Heart Diseases

Keywords

Plasma Homocysteine ConcentrationFolateHomocysteineSupplementsFolic Acid

Outcome Measures

Primary Outcomes (1)

  • Plasma homocysteine levels

    Measured at Week 6

Secondary Outcomes (1)

  • Serum folate levels

    Measured at Week 6

Study Arms (5)

1

PLACEBO COMPARATOR

Participants will receive placebo folic acid.

Drug: Placebo Folic Acid

2

EXPERIMENTAL

Participants will receive 100 mcg of folic acid.

Dietary Supplement: Folic Acid

3

EXPERIMENTAL

Participants will receive 400 mcg of folic acid.

Dietary Supplement: Folic Acid

4

EXPERIMENTAL

Participants will receive 1000 mcg of folic acid.

Dietary Supplement: Folic Acid

5

EXPERIMENTAL

Participants will receive 2000 mcg of folic acid.

Dietary Supplement: Folic Acid

Interventions

Folic AcidDIETARY_SUPPLEMENT

100 mcg, 400 mcg, 1000 mcg, or 2000 mcg of folic acid once a day for 6 weeks

Also known as: Folate
2345
Placebo Folic AcidDRUG

Placebo folic acid once a day for 6 weeks

1

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Living in the Baltimore area

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Diseases

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Lawrence J. Appel, MD, MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

December 10, 2008

First Posted

December 12, 2008

Study Start

June 1, 1996

Primary Completion

September 1, 1996

Study Completion

September 1, 1996

Last Updated

July 29, 2016

Record last verified: 2008-12