Folic Acid Supplementation in Eating Disorder
Folic Acid Supplementation for Improving Homocysteine Levels, Cognitive and Depressive Status in Eating Disorders
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 13, 2011
CompletedFirst Posted
Study publicly available on registry
December 16, 2011
CompletedDecember 16, 2011
December 1, 2011
2.4 years
December 13, 2011
December 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood variables monitored
serum folate, red blood cell folate, vitamin B12, plasma homocysteine
after 6 month of intervention
Secondary Outcomes (3)
Evolution on cognitive and depressive status
after 6 month of intervention
Anthropometric parameters
after 6 month of intervention
Dietary parameters
after 6 months of intervention
Study Arms (2)
placebo tablets
NO INTERVENTIONtwo identical tablets, but composed of crystalline cellulose, lactose and colouring
a suplemented group
EXPERIMENTALtwo 5-mg tablets of folic acid
Interventions
two 5-mg tablets of folic acid
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carmen Gómez Candela, MD
Nutrition Department. La Paz University Hospital. La Paz Health Research Institute.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Research and Clinical Trial Department
Study Record Dates
First Submitted
December 13, 2011
First Posted
December 16, 2011
Study Start
January 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
December 16, 2011
Record last verified: 2011-12