MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients

X-Linked Dystonia Parkinsonism Clinical Trial

— MINGO  

Official title:

MINGO Supplemental Trial in X-linked Dystonia Parkinsonism Patients: A Prospective Randomized, Open-labeled, Parallel Group Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019458
• Other study ID #: MINGO-001
• Status: Completed
• Phase: N/A
• Start date: February 10, 2017
• Est. completion date: June 26, 2017

Study information

• Verified date: April 2020
• Source: Sunshine Care Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 26, 2017
• Est. primary completion date: May 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Genetic Diseases, X-Linked
• Parkinsonian Disorders
• X-Linked Dystonia Parkinsonism

Intervention

Dietary Supplement:
• MINGO
6 20oz sachets will be taken daily by intervention group

Locations

Country	Name	City	State
Philippines	Health Centrum	Roxas City	Capiz

Sponsors (3)

Lead Sponsor	Collaborator
Sunshine Care Foundation	Jose R. Reyes Memorial Medical Center, Massachusetts General Hospital

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale.	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.	after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months
Secondary	All Cause Mortality	number of deaths in both arms at the end of the study	3 months (study close out)
Secondary	Number of Hospitalizations Secondary to Infectious Causes	number of hospitalizations secondary to infections in both arms at the end of the study	3 months (study close out)
Secondary	Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure	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	After baseline measurements, the investigators will measure the MUAC evey month for 3 months