MINGO Supplemental Trial in X-linked Dystonia Parkinsonism Patients: A Prospective Randomized, Open-labeled, Parallel Group Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale.
研究概览
简要总结
To see whether MINGO, a food supplement, will be able to lessen the drastic weight loss seen among X-linked Dystonia Parkinsonism patients.
详细描述
X-linked dystonia parkinsonism (XDP, formerly known as DYT3) occurs primarily in Filipino males and is characterized by neurodegenerative dystonia and parkinsonism. It is currently recognized to have wide phenotypic variability relating to age of onset, location of disease onset and rate of severity/disease progression. Most patients begin with focal dystonia that generalizes with the development of parkinsonism later in disease course. XDP patients suffer from severe nutritional loss due to symptoms such as dysphagia, loss of appetite, and consistently high metabolic requirements brought about by their movement disorder. Approximately 79% of patients with XDP have experienced rapid weight loss since the onset of their disease. It is the aim of the researchers to assess the clinical usefulness of adding a nutritional supplement to the daily dietary needs of these patients.
MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans, which can be added to any type of edible paste, food, and liquid. Mingo has gained popularity as an emergency food in disaster relief operations due to the ease of its preparation, its high nutritional value and relatively low price. For the last two years, it has also been used as an agent for nutritional build up in malnourished populations of children. This study will provide valuable information on whether patients with XDP can increase their weight by consuming MINGO, which will lead to improvements in the patients' medical care and wellbeing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is above the age of 18
- •Positive Diagnosis of XDP by movement disorder specialist/fellow
- •Subject with a yes response to a "supportive home environment" in the patient's most recent "doctors monthly report"
- •Subject are easily accessible to passable roads and pubic transportation
排除标准
- •Subjects who have extreme movements that prevent staff from performing BMI or MUAC measurements
- •Subjects who have abnormal metabolic labs prior to the start of the study
- •Subjects who are taking pharmacological or medicinal supplements that may effect weight
- •Subjects who have been hospitalized within the last 2 weeks from the start of the trial
- •Subjects who have a Nasogastric tube or G-tube
- •Subjects with a history of other diseases that my effect weight (eg: hypo/hyperthyroidism)
结局指标
主要结局
The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale.
时间窗: after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months
The investigators will first take a baseline Body Mass Index in kg/m\^2 for both control and intervention group, then subsequent measures every two weeks for 3 month duration of he trial. The goal of the investigators is to compare the net change in Body Mass Index in a 3 month period.
次要结局
- Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure(After baseline measurements, the investigators will measure the MUAC evey month for 3 months)
- All Cause Mortality(3 months (study close out))
- Number of Hospitalizations Secondary to Infectious Causes(3 months (study close out))