NCT00372645

Brief Summary

The aim of this study is to determine the best source of folate to raise the folate status of a general population over a 16 week intervention period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

2 active sites

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
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 24, 2015

Status Verified

February 1, 2013

Enrollment Period

2.7 years

First QC Date

September 6, 2006

Last Update Submit

March 23, 2015

Conditions

Healthy

Keywords

Healthy

Outcome Measures

Primary Outcomes (2)

  • Folate status

    Baseline and 16 weeks

  • Homocysteine status

    Baseline and 16 weeks

Secondary Outcomes (3)

  • Cardio vascular disease markers

    Baseline and 16 weeks

  • Inflammatory markers

    Baseline and 16 weeks

  • Pulse wave velocity

    Baseline and 16 weeks

Study Arms (4)

Diet

EXPERIMENTAL

200 µg folate per day from folate-rich foods

Other: Folate rich foods

Folic acid supplement

EXPERIMENTAL

200 µg folate per day from supplemental folic acid

Dietary Supplement: Folic acid (supplement)

Metfolin supplement

EXPERIMENTAL

200 µg folate per day from supplemental Metafolin®

Dietary Supplement: Metafolin (supplement)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Folic acid (supplement)DIETARY_SUPPLEMENT

200 µg folate per day from supplemental folic acid

Folic acid supplement
Metafolin (supplement)DIETARY_SUPPLEMENT

200 µg folate per day from supplemental Metafolin®

Metfolin supplement
PlaceboDRUG

Placebo

Placebo
Folate rich foodsOTHER

200 µg folate per day from folate-rich foods

Diet

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged 18-65 years
  • Smokers and non-smokers

You may not qualify if:

  • Pregnant or has been pregnant within the last 12 months
  • Breastfeeding
  • Has donated or intends to donate blood within 16 weeks of the first or last study samples
  • Fails standard clinical screening of blood and urine for human studies at the Institute of Food Reseach
  • BMI above 18 or below 40
  • Receiving vascular disease or anti-hypertensive drugs
  • Those with diabetes
  • Regularly consuming dietary supplements containing B-vitamins and/or folic acid.
  • \[As the capsules are prepared from gelatin, true vegetarians may not wish to participate\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

University of Sheffield

Sheffield, Yorkshire, S10 2FN, United Kingdom

Location

Related Links

MeSH Terms

Interventions

Folic Acidlevomefolate calcium

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Paul M Flingas, BSc

    Quadram Institute Bioscience

    PRINCIPAL INVESTIGATOR

  • Hilary Powers, BSc PhD

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 7, 2006

Study Start

May 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2012

Last Updated

March 24, 2015

Record last verified: 2013-02

Locations

GB(2)