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Folic Acid Supplementation in Eating Disorder

NCT ID: NCT01493674

Last Updated: 2011-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Eating Disorders

Keywords

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folate homocysteine cognitive function eating disorders depression.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo tablets

two identical tablets, but composed of crystalline cellulose, lactose and colouring

Group Type NO_INTERVENTION

No interventions assigned to this group

a suplemented group

two 5-mg tablets of folic acid

Group Type EXPERIMENTAL

folic acid

Intervention Type DIETARY_SUPPLEMENT

two 5-mg tablets of folic acid

Interventions

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folic acid

two 5-mg tablets of folic acid

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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folic acid (ACFOL®)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

OTHER

Sponsor Role lead

Responsible Party

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Ignacio Galicia

Head of Research and Clinical Trial Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carmen Gómez Candela, MD

Role: PRINCIPAL_INVESTIGATOR

Nutrition Department. La Paz University Hospital. La Paz Health Research Institute.

Locations

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Hospital Universitario La Paz

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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2007-004353-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HULP 2448

Identifier Type: -

Identifier Source: org_study_id