- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01493674
Folic Acid Supplementation in Eating Disorder
December 14, 2011 updated by: Ignacio Galicia, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Folic Acid Supplementation for Improving Homocysteine Levels, Cognitive and Depressive Status in Eating Disorders
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Madrid, Spain, 28046
- Hospital Universitario La Paz
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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
|
two 5-mg tablets of folic acid
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood variables monitored
Time Frame: after 6 month of intervention
|
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
Time Frame: after 6 month of intervention
|
Beck Depression Inventory Test Stroop colour-word interference test Trail Making Test
|
after 6 month of intervention
|
Anthropometric parameters
Time Frame: after 6 month of intervention
|
weight, body composition, food frequency questionnaire
|
after 6 month of intervention
|
Dietary parameters
Time Frame: after 6 months of intervention
|
Energy, macronutrients and micronutrients intake.
|
after 6 months of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Carmen Gómez Candela, MD, Nutrition Department. La Paz University Hospital. La Paz Health Research Institute.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (ACTUAL)
June 1, 2010
Study Completion (ACTUAL)
June 1, 2010
Study Registration Dates
First Submitted
December 13, 2011
First Submitted That Met QC Criteria
December 14, 2011
First Posted (ESTIMATE)
December 16, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
December 16, 2011
Last Update Submitted That Met QC Criteria
December 14, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HULP 2448
- 2007-004353-28 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eating Disorders
-
Bezmialem Vakif UniversityMuğla Sıtkı Koçman University; The Scientific and Technological Research Council... and other collaboratorsActive, not recruitingEating Disorders | Eating Behavior | Orthodontic Appliance Complication | Eating HabitTurkey
-
Shalvata Mental Health CenterUniversity of Haifa; The Touro College and University SystemUnknownBinge-Eating Disorder | Bulimia Nervosa | Night-eating Syndrome
-
Stanford UniversityNational Institute of Mental Health (NIMH)RecruitingEating DisorderUnited States
-
Cornell CollegeNational Institute of Mental Health (NIMH)Completed
-
McMaster UniversityCompletedEating DisorderCanada
-
Washington University School of MedicineCompletedEating Disorder
-
Laval UniversityCanadian Foundation for Dietetic Research (CFDR)Completed
-
Lindner Center of HOPEUniversity of CincinnatiCompleted
-
University of North Carolina, Chapel HillThe Hilda & Preston Davis Foundation; Global Foundation for Eating DisordersCompletedEating Disorder | Binge-eating DisorderUnited States
-
Stanford UniversityCompletedBinge Eating | Purging (Eating Disorders)United States
Clinical Trials on folic acid
-
Universität des SaarlandesCompletedthe Effect of MTHFR C677T on Folate MetabolismGermany
-
EndocyteCompleted
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Universidade Federal de GoiasFederal University of São Paulo; Ministry of Health, Brazil; Goiania Municipal...Completed
-
Centro Universitario de TonaláNot yet recruitingDrug Abuse | GenotoxicityMexico
-
Università degli Studi dell'InsubriaUniversita di VeronaNot yet recruitingPolycystic Ovary Syndrome
-
Zhao gengliVifor PharmaCompletedIron Deficiency Anemia | Iron DeficiencyChina
-
Wageningen Centre for Food SciencesWageningen UniversityCompletedHealthy | Folate BioavailabilityNetherlands
-
The Hospital for Sick ChildrenDuchesnay Inc.Completed
-
Università degli Studi dell'InsubriaUniversita di VeronaNot yet recruitingPolycystic Ovarian Syndrome | Infertility, Female