The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing
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| ClinicalTrials.gov Identifier: NCT00110604 |
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Recruitment Status :
Completed
First Posted : May 11, 2005
Last Update Posted : December 31, 2008
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atherosclerosis Vascular Disease Cognitive Decline Hearing Loss Inflammation Age-Related Memory Disorder | Behavioral: folic acid (0.8 mg) | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 835 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Prevention |
| Official Title: | The Folic Acid and Carotid Intima-Media Thickness (FACIT) Study: A Randomized Controlled Trial |
| Study Start Date : | September 2000 |
| Study Completion Date : | December 2004 |
- Change in mean carotid intima-media thickness
- Change in maximum carotid intima-media thickness
- 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
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| Ages Eligible for Study: | 50 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110604
| Netherlands | |
| Wageningen University | |
| Wageningen, Gelderland, Netherlands, 6700 EV | |
| Principal Investigator: | Petra Verhoef, PhD | Wageningen Centre for Food Sciences |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00110604 |
| Other Study ID Numbers: |
Pou.0224L ZonMw 20010002 |
| First Posted: | May 11, 2005 Key Record Dates |
| Last Update Posted: | December 31, 2008 |
| Last Verified: | May 2005 |
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Folic acid Atherosclerosis Cognitive function Hearing |
Inflammation Hemostasis Arterial stiffness |
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Hearing Loss Memory Disorders Atherosclerosis Vascular Diseases Inflammation Cognitive Dysfunction Pathologic Processes Arteriosclerosis Arterial Occlusive Diseases Cardiovascular Diseases Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders |
Neurologic Manifestations Nervous System Diseases Cognition Disorders Neurocognitive Disorders Mental Disorders Neurobehavioral Manifestations Folic Acid Hematinics Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs |