The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing
This study has been completed.
Sponsor:
Wageningen University
Collaborators:
Wageningen Centre for Food Sciences
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT00110604
First received: May 10, 2005
Last updated: December 29, 2008
Last verified: May 2005
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Purpose
The purpose of this study is to determine if folic acid supplementation can slow down atherosclerotic progression, age-related cognitive decline and age-related hearing loss.
| Condition | Intervention |
|---|---|
|
Atherosclerosis Vascular Disease Cognitive Decline Hearing Loss Inflammation Age-Related Memory Disorder |
Behavioral: folic acid (0.8 mg) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | The Folic Acid and Carotid Intima-Media Thickness (FACIT) Study: A Randomized Controlled Trial |
Resource links provided by NLM:
MedlinePlus related topics:
Atherosclerosis
B Vitamins
Hearing Disorders and Deafness
Memory
Vascular Diseases
U.S. FDA Resources
Further study details as provided by Wageningen University:
Primary Outcome Measures:
- Change in mean carotid intima-media thickness
- Change in maximum carotid intima-media thickness
Secondary Outcome Measures:
- Change in carotid distension
- Change in hearing levels (pure tone air conduction averages of 0.5, 1, and 2 kHz & 4, 6 and 8 kHz)
- Cognitive performance at year 3 (cognitive domains: simple speed, cognitive flexibility, and memory; and information processing speed and semantic memory)
- Inflammatory markers and hemostasis markers
| Estimated Enrollment: | 835 |
| Study Start Date: | September 2000 |
| Estimated Study Completion Date: | December 2004 |
Low levels of B vitamins, in particular folate, and high levels of plasma total homocysteine, have been associated with a variety of age-related diseases and disorders, including cardiovascular disease, dementia and hearing impairment. Extra folate, for example in the form of folic acid, is known to decrease the concentrations of plasma total homocysteine.
We examined whether 0.8 mg/d folic acid could slow down atherosclerotic progression and the above mentioned age-related processes.
Eligibility| Ages Eligible for Study: | 50 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 50-70 years
- Men and post-menopausal women
- Women with a surgically removed uterus were required to be >=55 years
Exclusion Criteria:
- Plasma total homocysteine <13 or >26 umol/L
- Serum vitamin B12 <200 pmol/L
- Self-reported current use of drugs which affect folate metabolism
- Self-reported current use of drugs believed to influence intima-media thickening, i.e., lipid-lowering drugs, hormone replacement therapy
- Self-reported medical diagnosis of renal, intestinal, thyroid disease
- Self-reported medical diagnosis of current cancer
- Self-reported current use of supplements containing B vitamins
- Self-reported inability or unwillingness to fast for 12 hours
- <80% compliance using placebo pills during a 6-week run-in period
- Not giving written informed consent
- Participation in other research studies
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110604
Locations
| Netherlands | |
| Wageningen University | |
| Wageningen, Gelderland, Netherlands, 6700 EV | |
Sponsors and Collaborators
Wageningen University
Wageningen Centre for Food Sciences
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
| Principal Investigator: | Petra Verhoef, PhD | Wageningen Centre for Food Sciences |
More Information
Additional Information:
No publications provided by Wageningen University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00110604 History of Changes |
| Other Study ID Numbers: | Pou.0224L, ZonMw 20010002 |
| Study First Received: | May 10, 2005 |
| Last Updated: | December 29, 2008 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Wageningen University:
|
Folic acid Atherosclerosis Cognitive function Hearing |
Inflammation Hemostasis Arterial stiffness |
Additional relevant MeSH terms:
|
Atherosclerosis Hearing Loss Deafness Inflammation Memory Disorders Vascular Diseases Cognition Disorders Arteriosclerosis Arterial Occlusive Diseases Cardiovascular Diseases Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Pathologic Processes Neurobehavioral Manifestations Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Folic Acid Vitamin B Complex Hematinics Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013