NCT02373033

Brief Summary

This study evaluates the effects of folate-rich foods regarding improvement of folate status compared with folic acid supplement. A randomized, parallel intervention trial with two active groups (folate-rich foods or folic acid supplement) and one control group (apple juice - 0 µg/d folate) was executed over 12 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
Last Updated

February 26, 2015

Status Verified

February 1, 2015

Enrollment Period

3 months

First QC Date

February 3, 2015

Last Update Submit

February 20, 2015

Conditions

Folic Acid Deficiency

Keywords

Folatefolic acidintervention trialfolate statuswomen in childbearing agefood folate

Outcome Measures

Primary Outcomes (2)

  • Change in plasma folate

    Assessment of plasma folate at baseline, 8 and 12 weeks

    (0 and 12 weeks)

  • Change in erythrocyte folate

    Assessment of erythrocyte folate at baseline, 8 and 12 weeks

    (0 and 12 weeks)

Secondary Outcomes (1)

  • Change in plasma total homocysteine

    (0 and 12 weeks)

Study Arms (3)

Intervention: Natural food folate

ACTIVE COMPARATOR

Food group consumed folate-rich foods (providing additional 250 μg/d folate).

Other: Natural food folate

Intervention: Folic acid

ACTIVE COMPARATOR

Folic acid group received a folic acid supplement (providing additional 500 μg/d folic acid).

Other: Folic acid

Intervention: Control

PLACEBO COMPARATOR

Control group received apple juice containing no folate or folic acid every day.

Other: Apple juice

Interventions

Natural food folateOTHER

Consumed folate-rich foods (providing additional 250 μg/d folate).

Also known as: Food folate
Intervention: Natural food folate
Folic acidOTHER

Received a folic acid supplement (providing additional 500 μg/d folic acid).

Intervention: Folic acid
Apple juiceOTHER

Received apple juice containing no folate or folic acid.

Intervention: Control

Eligibility Criteria

Age19 Years - 32 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal biochemical range for:
  • Fasted plasma glucose
  • Iron status (haemoglobin, serum ferritin)
  • Liver status (aspartate transaminase, alanine transaminase, and γ-glutamyl transferase activities)
  • Lipid profile (triglycerides, LDL, HDL)
  • Folate status (plasma and erythrocyte folate)
  • Plasma total homocysteine (tHcy)
  • Vitamin B-12

You may not qualify if:

  • History of acute or chronic disease
  • Use of vitamin or mineral supplements or folic acid fortified foods (within the past one month)
  • A body mass index (BMI, in kg/m2) \>18 and \<30
  • Any medication interfering with folate metabolism (e.g., antiepileptic drugs, antibiotics, methotrexate, sulfasalazine, or anticonvulsants), smokers, consuming special diets (vegetarian), pregnancy, planned conception or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

Related Publications (1)

  • Ohrvik VE, Olsson JC, Sundberg BE, Witthoft CM. Effect of 2 pieces of nutritional advice on folate status in Swedish women: a randomized controlled trial. Am J Clin Nutr. 2009 Apr;89(4):1053-8. doi: 10.3945/ajcn.2008.27192. Epub 2009 Feb 3.

    PMID: 19190070RESULT

MeSH Terms

Conditions

Folic Acid Deficiency

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Cornelia Witthöft, Prof

    Dept of Food Science, Swedish University of Agricultural Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 26, 2015

Study Start

March 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 26, 2015

Record last verified: 2015-02

Locations

EG(1)