Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children: a Randomized Double Blinded Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes of Homocysteine Level
研究概览
简要总结
The purpose of the present study was to determine whether folic acid supplementation could reduce plasma homocysteine in obese children and to determine the association between dietary folate, serum folate and homocysteine level through the randomized double blinded placebo controlled trial.
详细描述
Atherosclerosis is common & remains a significant clinical problem because of leading to myocardial infarction, stroke and cardiovascular death. Many studies founded hyperhomocysteinemia is an independent risk factor for those cardiovascular diseases which take responsible for about 10% of total cardiovascular disease risk. Reduction of elevated plasma homocysteine may prevent up to 25% of cardiovascular events. One of modifiable cause of hyperhomocysteinemia is prevention of vitamin deficiency, especially folate deficiency.
Obese Thai children are probable risk for folate deficiency due to low dietary folate intake and low serum folate level from unbalanced diet (low vegetables intake & high fat diet) and high prevalence of thalassemia. Moreover obese children are also at risk of atherosclerosis. However, no data have been reported about effect of folic acid supplementation on homocysteine level in these patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age between 9-18 years
- •Diagnosed obesity (BMI more than median plus two of standard deviation for age and sex according to WHO reference 2007)
排除标准
- •Secondary obesity
- •Thalassemia disease
- •Renal and hepatic dysfunction
- •Drugs: anticonvulsant, estrogen, thiazides, metformin, cholestyramine, methotrexate, fibrates, nicotinic acid
- •Previous vitamin supplementation 1 month before study
研究组 & 干预措施
placebo
placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study
干预措施: placebo (Drug)
folic acid
Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study
干预措施: Folic Acid (Drug)
结局指标
主要结局
Changes of Homocysteine Level
时间窗: 8 weeks
Mean difference of changes of homocysteine level between 2 treatment groups
次要结局
- Serum Vitamin B12 Level(8 weeks)
- Serum Folate Level(8 weeks)
研究者
Pavinee Intakorn
Queen Sirikit National Institute of Child Health
Queen Sirikit National Institute of Child Health