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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004353-28 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| folic acid | Dietary Supplement | two 5-mg tablets of folic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood variables monitored | serum folate, red blood cell folate, vitamin B12, plasma homocysteine | after 6 month of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution on cognitive and depressive status | Beck Depression Inventory Test Stroop colour-word interference test Trail Making Test | after 6 month of intervention |
| Anthropometric parameters | weight, body composition, food frequency questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Gómez Candela, MD | Nutrition Department. La Paz University Hospital. La Paz Health Research Institute. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
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| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| after 6 month of intervention |
| Dietary parameters | Energy, macronutrients and micronutrients intake. | after 6 months of intervention |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006571 | Heterocyclic Compounds |