Eating DisordersPhase 4NCT01493674
Folic Acid Supplementation in Eating Disorder
A Phase 4 study testing folic acid in people with Eating Disorders, run by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders
- What is being tested?
- folic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2008to Jun 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Eating Disorders
- Being tested
- folic acid
- Keywords
- folate, homocysteine, cognitive function, eating disorders, depression.
- Medical subject headings
- Feeding and Eating Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
folic acidDietary supplement
Also called folic acid (ACFOL®)
two 5-mg tablets of folic acid
| Study group | Role | What they receive |
|---|---|---|
| placebo tablets | No intervention | two identical tablets, but composed of crystalline cellulose, lactose and colouring |
| a suplemented group | Experimental | two 5-mg tablets of folic acid Receives: Dietary Supplement: folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood variables monitored
serum folate, red blood cell folate, vitamin B12, plasma homocysteine
Measured: after 6 month of intervention
Secondary outcomes (3)
Evolution on cognitive and depressive status
Beck Depression Inventory Test Stroop colour-word interference test Trail Making Test
Measured: after 6 month of intervention
Anthropometric parameters
weight, body composition, food frequency questionnaire
Measured: after 6 month of intervention
Dietary parameters
Energy, macronutrients and micronutrients intake.
Measured: after 6 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Galicia, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
- Investigators
- Carmen Gómez Candela, MD, Principal investigator, Nutrition Department. La Paz University Hospital. La Paz Health Research Institute.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493674
- Sponsor's protocol ID
- HULP 2448
- Other IDs
- 2007-004353-28
- Status last verified
- Dec 2011
- First submitted
- 13 Dec 2011
- Last updated
- 16 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Folic Acid Supplementation for Improving Homocysteine Levels, Cognitive and Depressive Status in Eating Disorders
- ClinicalTrials.gov ID
- NCT01493674
- Acronym / sponsor ID
- HULP 2448
- Conditions
- Eating Disorders
- Keywords
- folate, homocysteine, cognitive function, eating disorders, depression.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario la PazUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo tablets | No intervention | –two identical tablets, but composed of crystalline cellulose, lactose and colouring |
| a suplemented group | Experimental | Dietary Supplement: folic acidtwo 5-mg tablets of folic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| folic acidAlso: folic acid (ACFOL®)two 5-mg tablets of folic acid | Dietary supplement | a suplemented group |
Primary outcome
Blood variables monitored
Time frame: after 6 month of intervention
serum folate, red blood cell folate, vitamin B12, plasma homocysteine
3 secondary outcomes
Evolution on cognitive and depressive status
Time frame: after 6 month of intervention
Anthropometric parameters
Time frame: after 6 month of intervention
Dietary parameters
Time frame: after 6 months of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Gómez Candela, MD principal investigator
Nutrition Department. La Paz University Hospital. La Paz Health Research Institute.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing folic acid in people with Eating Disorders, run by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood variables monitored (time frame: after 6 month of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2011.