Clinical trial NCT03019458: MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients
Official title: MINGO Supplemental Trial in X-linked Dystonia Parkinsonism Patients: A Prospective Randomized, Open-labeled, Parallel Group Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: X-Linked Dystonia Parkinsonism
Keywords: prospective randomized trial
Lead sponsor: Sunshine Care Foundation
Sponsor class: OTHER
Collaborators: name: Jose R. Reyes Memorial Medical Center
name: Massachusetts General Hospital
First posted: 2017-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To see whether MINGO, a food supplement, will be able to lessen the drastic weight loss seen among X-linked Dystonia Parkinsonism patients.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale.
timeFrame: after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months
Secondary outcomes:
measure: All Cause Mortality
timeFrame: 3 months (study close out)
measure: Number of Hospitalizations Secondary to Infectious Causes
timeFrame: 3 months (study close out)
measure: Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure
timeFrame: After baseline measurements, the investigators will measure the MUAC evey month for 3 months
Other outcomes:
Locations:
city: Roxas City
country: Philippines
facility: Health Centrum
state: Capiz
Study officials:
affiliation: Jose R. Reyes Memorial Medical Center
name: Criscely L Go, MD,FPNA,DPBP
role: PRINCIPAL_INVESTIGATOR
References: