MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients (MINGO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03019458|
Recruitment Status : Completed
First Posted : January 12, 2017
Last Update Posted : June 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|X-Linked Dystonia Parkinsonism||Dietary Supplement: MINGO||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||MINGO Supplemental Trial in X-linked Dystonia Parkinsonism Patients: A Prospective Randomized, Open-labeled, Parallel Group Trial|
|Actual Study Start Date :||February 10, 2017|
|Actual Primary Completion Date :||May 8, 2017|
|Actual Study Completion Date :||June 26, 2017|
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. The experimental group is required to take 6 sachets per day for 12 weeks in addition to their regular diet. They are required to keep a daily food diary
Dietary Supplement: MINGO
6 20oz sachets will be taken daily by intervention group
No Intervention: Control
The control group is required to eat their normal diet. They are also required to keep a daily food diary.
- The change in Body Mass Index (BMI in kg/m2) from baseline using a bathroom weighing scale. [ Time Frame: after baseline BMI, we will measure BMI every 2 weeks for 3 months ]The investigators will first take a baseline BMI in kg/m2 for both control and interventional 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 BMI in a 3 month period.
- all cause mortality [ Time Frame: 3 months (study close out) ]number of deaths in both arms at the end of the study
- number of hospitalizations secondary to infectious causes [ Time Frame: 3 months (study close out) ]number of hospitalizations secondary to infections in both arms at the end of the study
- Change in Mid Upper Arm Circumference (MUAC) in cm using a tailor's tape measure from baseline. [ Time Frame: After baseline measurements, the investigators will measure the MUAC evey month for 3 months ]It has been reported that the Mid Upper Arm Circumference is a good predictor for BMI. It will serve as an indirect measurement to the subjects' BMI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019458
|Roxas City, Capiz, Philippines, 5800|
|Principal Investigator:||Criscely L Go, MD,FPNA,DPBP||Jose R. Reyes Memorial Medical Center|