Folic Acid Supplementation in Eating Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ignacio Galicia, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
ClinicalTrials.gov Identifier:
NCT01493674
First received: December 13, 2011
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Eating Disorders
Dietary Supplement: folic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Folic Acid Supplementation for Improving Homocysteine Levels, Cognitive and Depressive Status in Eating Disorders

Resource links provided by NLM:


Further study details as provided by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz:

Primary Outcome Measures:
  • Blood variables monitored [ Time Frame: after 6 month of intervention ] [ Designated as safety issue: No ]
    serum folate, red blood cell folate, vitamin B12, plasma homocysteine


Secondary Outcome Measures:
  • Evolution on cognitive and depressive status [ Time Frame: after 6 month of intervention ] [ Designated as safety issue: No ]
    Beck Depression Inventory Test Stroop colour-word interference test Trail Making Test

  • Anthropometric parameters [ Time Frame: after 6 month of intervention ] [ Designated as safety issue: No ]
    weight, body composition, food frequency questionnaire

  • Dietary parameters [ Time Frame: after 6 months of intervention ] [ Designated as safety issue: Yes ]
    Energy, macronutrients and micronutrients intake.


Enrollment: 24
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493674

Locations
Spain
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Investigators
Principal Investigator: Carmen Gómez Candela, MD Nutrition Department. La Paz University Hospital. La Paz Health Research Institute.
  More Information

No publications provided

Responsible Party: Ignacio Galicia, Head of Research and Clinical Trial Department, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
ClinicalTrials.gov Identifier: NCT01493674     History of Changes
Other Study ID Numbers: HULP 2448, 2007-004353-28
Study First Received: December 13, 2011
Last Updated: December 14, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz:
folate
homocysteine
cognitive function
eating disorders
depression.

Additional relevant MeSH terms:
Eating Disorders
Mental Disorders
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014