MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients

NCT03019458 | Completed Results

• 1 other identifier: MINGO-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

X-Linked Dystonia Parkinsonism

Keywords

prospective randomized trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• All Cause Mortality

  3 months (study close out)

• Number of Hospitalizations Secondary to Infectious Causes

  3 months (study close out)

• 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

Study Arms (2)

MINGO

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

MINGO DIETARY_SUPPLEMENT

6 20oz sachets will be taken daily by intervention group

MINGO

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunshine Care Foundation: lead
• Jose R. Reyes Memorial Medical Center: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Health Centrum

Roxas City, Capiz, 5800, Philippines

Location

MeSH Terms

Conditions

Dystonia 3, Torsion, X-Linked

Limitations and Caveats

A major limitation to this trial is that it was a community-based clinical trial that relied on 14 CHWs to measure the weight and MUAC due to the far distance and difficult terrain. The accuracy of subject's food diary is a limitation.

Results Point of Contact

• Title: Dr. Patrick Acuna
• Organization: Sunshine Care Foundation

patrick_acuna@hotmail.com

+63 947 959-1851

Study Officials

• Criscely L Go, MD,FPNA,DPBP

  Jose R. Reyes Memorial Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 12, 2017
• Study Start: February 10, 2017
• Primary Completion: May 8, 2017
• Study Completion: June 26, 2017
• Last Updated: April 30, 2020
• Results First Posted: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)