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Completed

NCT Number: NCT01493674

Folic Acid Supplementation in Eating Disorder

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.

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Key information

Conditions

Eating Disorders Behavior Behavioral Symptoms Depression Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario La Paz

Madrid, 28046, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Folic Acid

Dietary Supplement

two 5-mg tablets of folic acid

Other names: folic acid (ACFOL®)

Primary outcomes

  1. Blood variables monitored

    Time frame: after 6 month of intervention

    serum folate, red blood cell folate, vitamin B12, plasma homocysteine

Secondary outcomes

  1. 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

  2. Anthropometric parameters

    Time frame: after 6 month of intervention

    weight, body composition, food frequency questionnaire

  3. Dietary parameters

    Time frame: after 6 months of intervention

    Energy, macronutrients and micronutrients intake.

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 16, 2011
Registry last updated
Dec 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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