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Folic Acid Supplementation in Eating Disorder

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01493674
Enrollment
24
Registered
2011-12-16
Start date
2008-01-31
Completion date
2010-06-30
Last updated
2011-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorders

Keywords

folate, homocysteine, cognitive function, eating disorders, depression.

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTfolic acid

two 5-mg tablets of folic acid

Sponsors

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Blood variables monitoredafter 6 month of interventionserum folate, red blood cell folate, vitamin B12, plasma homocysteine

Secondary

MeasureTime frameDescription
Evolution on cognitive and depressive statusafter 6 month of interventionBeck Depression Inventory Test Stroop colour-word interference test Trail Making Test
Anthropometric parametersafter 6 month of interventionweight, body composition, food frequency questionnaire
Dietary parametersafter 6 months of interventionEnergy, macronutrients and micronutrients intake.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026