Folic Acid Supplementation in Eating Disorder

Study Overview
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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.

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

Conditions
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Eating Disorders

Intervention / Treatment
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* Dietary Supplement: folic acid


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: placebo tablets<br>two identical tablets, but composed of crystalline cellulose, lactose and colouring | |
| Experimental: a suplemented group<br>two 5-mg tablets of folic acid | Dietary Supplement: folic acid<br>* two 5-mg tablets of folic acid<br>* Other names: folic acid (ACFOL®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood variables monitored | serum folate, red blood cell folate, vitamin B12, plasma homocysteine | after 6 month of intervention | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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folate, homocysteine, cognitive function, eating disorders, depression.