Randomized Double Blind Levothyroxine vs Placebo, Mind (NEUROPSI) Improvement in Elderly With Persistent TSH 4-10 mUI/L
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in cognitive ability measured by NEUROPSI increase of 10 points
研究概览
简要总结
Some recommendations of expert consensus on subclinical hypothyroidism (SH) are controversial in those areas with not enough information to reach a conclusion, such as not recommending treatment with thyrotrophic hormone of 4-10 mUI/L and free thyroxin in normal range. The body changes or symptoms at this stage are often mistaken as aging. There are studies showing significant changes in heart (slow rate, lower ejection fraction, diastolic dysfunction); hypercholesterolemia, dysfunction cognitive abilities (memory attention...).
The prevalence of SH increases with age, reaching 14% over 65 years old. This age group increase as the population ages highlights the need for evidence to improve recommendations for the elderly.
NEUROPSI is a validated neuropsychological test sensible for mild cognitive alterations. It can be applied to individuals with little schooling.
This study aims to determine positive change in cognitive abilities (NEUROPSI), ejection fraction, and body percent of lean and adipose tissue without adverse effects, placebo versus thyroxin supplement to keep thyroid-stimulating hormone (TSH) between 0.5-2.5 mUI/L in elderly with TSH 4-10 mIU/L.
详细描述
Screening, subjects > 59 y/o with out exclusion criteria to identify HS, started in October 15, 2008. Due to difficulties getting the placebo for the assay, by January halted the screening. At the end of May we got the donation from Merck pharmaceuticals.
The protocol original dates changed as follows:
- Restart screening June 20 to end in August 2009;
- Enrolling start at the end of June (the already identified);
- End enrolling October 2009;
- Follow up will end in May 2010.
Note: 150 of the screened subjects will be from randomly selected homes at Fomerrey 19 to allow prevalence estimation.
- Enroling ended until june 2010
- Follow up stil ungoing final measures will be done at the end of 2011
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TSH between 4 and 10 mUI/L inclusive
排除标准
- •Known and treatment of thyroideal disease
- •Arrythmia
- •Anticoagulant treatment
- •Disease leading to dementia (acv, LIVER....)
研究组 & 干预措施
Levothyroxine
Half of participants randomly assigned, take a pill daily, bimonthly thyroid test
干预措施: levothyroxine sodium (Drug)
Placebo
Half of participants randomly assigned, take a pill daily, bimonthly thyroid test
干预措施: excipient without levothyroxine (placebo) (Drug)
结局指标
主要结局
Change in cognitive ability measured by NEUROPSI increase of 10 points
时间窗: baseline and after 6 months of treatment
ejection fraction, left ventricular diastolic capacity
时间窗: baseline, after six months of treatment
Lipid profile and body composition by DEXA
时间窗: baseline, after six months of treatment
次要结局
- clinical assessment v.g. significant changes in cardiac frequency and rhythm (if needed able to take EKG to confirm)(bimonthly)
- Free tiroxina and TSH (assessed by investigator other than treatment physician)(bimonthly)
- Changes in EKG(baseline, at six months, or as needed)
研究者
Lilia Csrdenas-Ibarra
MD
Universidad Autonoma de Nuevo Leon