Folic Acid Supplementation in Eating Disorder

December 14, 2011 updated by: Ignacio Galicia, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Folic Acid Supplementation for Improving Homocysteine Levels, Cognitive and Depressive Status in Eating Disorders

The aim of this study was to determine the effect of folic acid supplementation on homocysteine levels in a group of patients with eating disorders (ED) with low folate intake. The secondary aims were to evaluate the evolution on cognitive and depressive status after the intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Some authors have identified the presence of increased levels of homocysteine in patients with eating disorders and attempts have been made to find some association between this and the high rates of depression and cognitive function impairment recorded in these patients. It is still not known what causes this increase in homocysteine levels, whether the levels return to normal after the nutritional state is normalised and what strategies must be employed to carry out this normalisation.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females diagnosed with eating disorders (DSM-IV criteria of the American Psychiatric Association, 2000)
  • Age > 18 years
  • Low folate intake based on the recommended daily intake in terms of age (Institute of Medicine, 1998)

Exclusion Criteria:

  • Patients with contraindications for folic acid supplementation due to hypersensitivity to folic acid or anaemia due to lack of B12
  • Patients who routinely used drugs that interfere with folic acid absorption (analgesics, anticonvulsants, hydantoin, carbamazepine, antacids, antibiotics, cholestyramine, methotrexate, pyrimethamine, triamterene, trimethoprim and sulphonamides)
  • Patients with vitamin and mineral supplements intake.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: placebo tablets
two identical tablets, but composed of crystalline cellulose, lactose and colouring
EXPERIMENTAL: a suplemented group
two 5-mg tablets of folic acid
Dietary supplement: folic acid
two 5-mg tablets of folic acid
Other Names:
  • folic acid (ACFOL®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood variables monitored
Time Frame: after 6 month of intervention
serum folate, red blood cell folate, vitamin B12, plasma homocysteine
after 6 month of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution on cognitive and depressive status
Time Frame: after 6 month of intervention
Beck Depression Inventory Test Stroop colour-word interference test Trail Making Test
after 6 month of intervention
Anthropometric parameters
Time Frame: after 6 month of intervention
weight, body composition, food frequency questionnaire
after 6 month of intervention
Dietary parameters
Time Frame: after 6 months of intervention
Energy, macronutrients and micronutrients intake.
after 6 months of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Investigators

  • Principal Investigator: Carmen Gómez Candela, MD, Nutrition Department. La Paz University Hospital. La Paz Health Research Institute.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

December 14, 2011

First Posted (ESTIMATE)

December 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 16, 2011

Last Update Submitted That Met QC Criteria

December 14, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HULP 2448
  • 2007-004353-28 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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