Back to resultsFolic Acid Supplementation in Eating Disorder
Primary Purpose
Eating Disorders
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
folic acid
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorders focused on measuring folate, homocysteine, cognitive function, eating disorders, depression.
Eligibility 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.
Sites / Locations
- Hospital Universitario La Paz
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
placebo tablets
a suplemented group
Arm Description
two identical tablets, but composed of crystalline cellulose, lactose and colouring
two 5-mg tablets of folic acid
Outcomes
Primary Outcome Measures
Blood variables monitored
serum folate, red blood cell folate, vitamin B12, plasma homocysteine
Secondary Outcome Measures
Evolution on cognitive and depressive status
Beck Depression Inventory Test Stroop colour-word interference test Trail Making Test
Anthropometric parameters
weight, body composition, food frequency questionnaire
Dietary parameters
Energy, macronutrients and micronutrients intake.
Full Information
NCT ID
NCT01493674
First Posted
December 13, 2011
Last Updated
December 14, 2011
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
1. Study Identification
Unique Protocol Identification Number
NCT01493674
Brief Title
Folic Acid Supplementation in Eating Disorder
Official Title
Folic Acid Supplementation for Improving Homocysteine Levels, Cognitive and Depressive Status in Eating Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
folate, homocysteine, cognitive function, eating disorders, depression.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo tablets
Arm Type
No Intervention
Arm Description
two identical tablets, but composed of crystalline cellulose, lactose and colouring
Arm Title
a suplemented group
Arm Type
Experimental
Arm Description
two 5-mg tablets of folic acid
Intervention Type
Dietary Supplement
Intervention Name(s)
folic acid
Other Intervention Name(s)
folic acid (ACFOL®)
Intervention Description
two 5-mg tablets of folic acid
Primary Outcome Measure Information:
Title
Blood variables monitored
Description
serum folate, red blood cell folate, vitamin B12, plasma homocysteine
Time Frame
after 6 month of intervention
Secondary Outcome Measure Information:
Title
Evolution on cognitive and depressive status
Description
Beck Depression Inventory Test Stroop colour-word interference test Trail Making Test
Time Frame
after 6 month of intervention
Title
Anthropometric parameters
Description
weight, body composition, food frequency questionnaire
Time Frame
after 6 month of intervention
Title
Dietary parameters
Description
Energy, macronutrients and micronutrients intake.
Time Frame
after 6 months of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gómez Candela, MD
Organizational Affiliation
Nutrition Department. La Paz University Hospital. La Paz Health Research Institute.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
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Folic Acid Supplementation in Eating Disorder
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