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Folic Acid Supplementation in Eating Disorder

F

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Status and phase

Completed
Phase 4

Conditions

Eating Disorders

Treatments

Dietary Supplement: folic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT01493674
2007-004353-28 (EudraCT Number)
HULP 2448

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 2 patient groups

placebo tablets
No Intervention group
Description:
two identical tablets, but composed of crystalline cellulose, lactose and colouring
a suplemented group
Experimental group
Description:
two 5-mg tablets of folic acid
Treatment:
Dietary Supplement: folic acid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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