Folic Acid Supplementation in Eating Disorder

Eating Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493674
• Other study ID #: HULP 2448
• Secondary ID: 2007-004353-28
• Status: Completed
• Phase: Phase 4
• First received: December 13, 2011
• Last updated: December 14, 2011
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: December 2011
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eating Disorders

Intervention

Dietary Supplement:
• folic acid
two 5-mg tablets of folic acid

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood variables monitored	serum folate, red blood cell folate, vitamin B12, plasma homocysteine	after 6 month of intervention	No
Secondary	Evolution on cognitive and depressive status	Beck Depression Inventory Test Stroop colour-word interference test Trail Making Test	after 6 month of intervention	No
Secondary	Anthropometric parameters	weight, body composition, food frequency questionnaire	after 6 month of intervention	No
Secondary	Dietary parameters	Energy, macronutrients and micronutrients intake.	after 6 months of intervention	Yes