Folic Acid Supplementation in Eating Disorder

Overview

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.

Full Title of Study: “Folic Acid Supplementation for Improving Homocysteine Levels, Cognitive and Depressive Status in Eating Disorders”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 2010

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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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
  • Anthropometric parameters
    • Time Frame: after 6 month of intervention
    • weight, body composition, food frequency questionnaire
  • Dietary parameters
    • Time Frame: after 6 months of intervention
    • Energy, macronutrients and micronutrients intake.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ignacio Galicia, Head of Research and Clinical Trial Department – Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
  • Overall Official(s)
    • Carmen Gómez Candela, MD, Principal Investigator, Nutrition Department. La Paz University Hospital. La Paz Health Research Institute.

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