NCT00130585

Brief Summary

The main objectives of this project are:

  1. 1.to determine the relative bioavailability of dietary folate from a total diet, compared with synthetic folic acid and
  2. 2.to determine the bioavailability with a higher precision than previous methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2005

Completed
Last Updated

October 4, 2005

Status Verified

August 1, 2005

First QC Date

August 12, 2005

Last Update Submit

October 3, 2005

Conditions

Folate BioavailabilityHealthy

Keywords

FolateBioavailabilityStable isotopes

Outcome Measures

Primary Outcomes (2)

  • Bioavailability based on change in labelled folate concentration in plasma;

  • Bioavailability based on change in folate concentration in plasma

Secondary Outcomes (1)

  • Bioavailability based on change in concentration in plasma homocysteine

Interventions

Controlled dietBEHAVIORAL
folic acid supplementBEHAVIORAL
13C11-labelled folic acid supplementBEHAVIORAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Serum B12 \>118pmol/L;
  • Serum creatinine \<125micromol/L;
  • Plasma total homocysteine \<26micromol/L.

You may not qualify if:

  • Cardiovascular disease, cancer, rheumatoid arthritis, epilepsy, gastro-intestinal disorders;
  • Use of drugs interfering with folate metabolism;
  • Use of B vitamins within the period three months prior to the study.
  • Body Mass Index (BMI) \> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, 6700EV, Netherlands

Location

Study Officials

  • Petra Verhoef, Dr.

    Wageningen Centre for Food Sciences

    PRINCIPAL INVESTIGATOR

  • Martijn Katan, Professor

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 12, 2005

First Posted

August 15, 2005

Study Start

May 1, 2005

Study Completion

June 1, 2005

Last Updated

October 4, 2005

Record last verified: 2005-08

Locations

NL(1)