Folic Acid Supplementation in Eating Disorder

Phase 4

Completed

• Conditions: Eating Disorders
• Interventions: Dietary Supplement: folic acid

• Registration Number: NCT01493674
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2011-12
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2011-12-14
• Last Update Submitted: 2011-12-14
• Study First Posted: 2011-12-16
• Last Update Posted: 2011-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
a suplemented group	folic acid	two 5-mg tablets of folic acid

Primary Outcome Measures

Name	Time	Method
Blood variables monitored	after 6 month of intervention	serum folate, red blood cell folate, vitamin B12, plasma homocysteine

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain