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MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients (MINGO)

Primary Purpose

X-Linked Dystonia Parkinsonism

Status
Completed
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
MINGO
Sponsored by
Sunshine Care Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for X-Linked Dystonia Parkinsonism focused on measuring prospective randomized trial

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Health Centrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MINGO

Control

Arm Description

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

The control group is required to eat their normal diet. They are also required to keep a daily food diary.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

All Cause Mortality
number of deaths in both arms at the end of the study
Number of Hospitalizations Secondary to Infectious Causes
number of hospitalizations secondary to infections in both arms at the end of the study
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

Full Information

First Posted
January 9, 2017
Last Updated
April 20, 2020
Sponsor
Sunshine Care Foundation
Collaborators
Jose R. Reyes Memorial Medical Center, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03019458
Brief Title
MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients
Acronym
MINGO
Official Title
MINGO Supplemental Trial in X-linked Dystonia Parkinsonism Patients: A Prospective Randomized, Open-labeled, Parallel Group Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
May 8, 2017 (Actual)
Study Completion Date
June 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Care Foundation
Collaborators
Jose R. Reyes Memorial Medical Center, Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
X-Linked Dystonia Parkinsonism
Keywords
prospective randomized trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MINGO
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group is required to eat their normal diet. They are also required to keep a daily food diary.
Intervention Type
Dietary Supplement
Intervention Name(s)
MINGO
Intervention Description
6 20oz sachets will be taken daily by intervention group
Primary Outcome Measure Information:
Title
The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale.
Description
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.
Time Frame
after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months
Secondary Outcome Measure Information:
Title
All Cause Mortality
Description
number of deaths in both arms at the end of the study
Time Frame
3 months (study close out)
Title
Number of Hospitalizations Secondary to Infectious Causes
Description
number of hospitalizations secondary to infections in both arms at the end of the study
Time Frame
3 months (study close out)
Title
Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure
Description
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
Time Frame
After baseline measurements, the investigators will measure the MUAC evey month for 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Criscely L Go, MD,FPNA,DPBP
Organizational Affiliation
Jose R. Reyes Memorial Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Centrum
City
Roxas City
State/Province
Capiz
ZIP/Postal Code
5800
Country
Philippines

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients

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