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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00110604
Other study ID # Pou.0224L
Secondary ID ZonMw 20010002
Status Completed
Phase N/A
First received May 10, 2005
Last updated December 29, 2008
Start date September 2000
Est. completion date December 2004

Study information

Verified date May 2005
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 835
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Intervention

Behavioral:
folic acid (0.8 mg)


Locations

Country Name City State
Netherlands Wageningen University Wageningen Gelderland

Sponsors (3)

Lead Sponsor Collaborator
Wageningen University Wageningen Centre for Food Sciences, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in mean carotid intima-media thickness
Primary Change in maximum carotid intima-media thickness
Secondary Change in carotid distension
Secondary Change in hearing levels (pure tone air conduction averages of 0.5, 1, and 2 kHz & 4, 6 and 8 kHz)
Secondary Cognitive performance at year 3 (cognitive domains: simple speed, cognitive flexibility, and memory; and information processing speed and semantic memory)
Secondary Inflammatory markers and hemostasis markers
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