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Folic Acid Supplementation in Eating Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01493674
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : December 16, 2011
Information provided by (Responsible Party):
Ignacio Galicia, 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.

Condition or disease Intervention/treatment Phase
Eating Disorders Dietary Supplement: folic acid Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Folic Acid Supplementation for Improving Homocysteine Levels, Cognitive and Depressive Status in Eating Disorders
Study Start Date : January 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Dietary Supplement: folic acid
two 5-mg tablets of folic acid
Other Name: folic acid (ACFOL®)

Primary Outcome Measures :
  1. Blood variables monitored [ Time Frame: after 6 month of intervention ]
    serum folate, red blood cell folate, vitamin B12, plasma homocysteine

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01493674

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Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
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Principal Investigator: Carmen Gómez Candela, MD Nutrition Department. La Paz University Hospital. La Paz Health Research Institute.
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Responsible Party: Ignacio Galicia, Head of Research and Clinical Trial Department, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz Identifier: NCT01493674    
Other Study ID Numbers: HULP 2448
2007-004353-28 ( EudraCT Number )
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: December 16, 2011
Last Verified: December 2011
Keywords provided by Ignacio Galicia, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz:
cognitive function
eating disorders
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Pathologic Processes
Mental Disorders
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs