Folic Acid Supplementation for Improving Homocysteine Levels, Cognitive and Depressive Status in Eating Disorders
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Blood variables monitored
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Blood variables monitored
时间窗: after 6 month of intervention
serum folate, red blood cell folate, vitamin B12, plasma homocysteine
次要结局
- 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)
研究者
Ignacio Galicia
Head of Research and Clinical Trial Department
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz