X-Linked Dystonia ParkinsonismMINGONCT03019458
MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients
A study testing MINGO in people with X-Linked Dystonia Parkinsonism, run by Sunshine Care Foundation at 1 site in Philippines.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- X-Linked Dystonia Parkinsonism
- What is being tested?
- MINGO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePhilippines
- Study dates
- 10 Feb 2017to 26 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MINGO Supplemental Trial in X-linked Dystonia Parkinsonism Patients: A Prospective Randomized, Open-labeled, Parallel Group Trial
To see whether MINGO, a food supplement, will be able to lessen the drastic weight loss seen among X-linked Dystonia Parkinsonism patients.
Read the 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.
- Conditions
- X-Linked Dystonia Parkinsonism
- Being tested
- MINGO
- Keywords
- prospective randomized trial
- Medical subject headings
- Dystonia 3, Torsion, X-Linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINGODietary supplement
6 20oz sachets will be taken daily by intervention group
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months
Secondary outcomes (3)
All Cause Mortality
number of deaths in both arms at the end of the study
Measured: 3 months (study close out)
Number of Hospitalizations Secondary to Infectious Causes
number of hospitalizations secondary to infections in both arms at the end of the study
Measured: 3 months (study close out)
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
Measured: After baseline measurements, the investigators will measure the MUAC evey month for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start10 Feb 2017
- Primary completion8 May 2017
- Study completion26 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for X-Linked Dystonia ParkinsonismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Care Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Jose R. Reyes Memorial Medical Center, Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Criscely L Go, MD,FPNA,DPBP, Principal investigator, Jose R. Reyes Memorial Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019458
- Sponsor's protocol ID
- MINGO-001
- Acronym
- MINGO
- Status last verified
- Apr 2020
- First submitted
- 9 Jan 2017
- Last updated
- 30 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MINGO Supplemental Trial in X-linked Dystonia Parkinsonism Patients: A Prospective Randomized, Open-labeled, Parallel Group Trial
- ClinicalTrials.gov ID
- NCT03019458
- Acronym / sponsor ID
- MINGO / MINGO-001
- Conditions
- X-Linked Dystonia Parkinsonism
- Keywords
- prospective randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sunshine Care FoundationUniversity, hospital or other
- Collaborators
- Jose R. Reyes Memorial Medical Center, Massachusetts General Hospital
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 8 May 2017 (actual)
- Study completion
- 26 Jun 2017 (actual)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Posted 6 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINGO | Experimental | Dietary Supplement: MINGOMINGO 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 |
| Control | No intervention | –The control group is required to eat their normal diet. They are also required to keep a daily food diary. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MINGO6 20oz sachets will be taken daily by intervention group | Dietary supplement | MINGO |
Primary outcome
The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale.
Time frame: after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months
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.
3 secondary outcomes
All Cause Mortality
Time frame: 3 months (study close out)
Number of Hospitalizations Secondary to Infectious Causes
Time frame: 3 months (study close out)
Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure
Time frame: After baseline measurements, the investigators will measure the MUAC evey month for 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Criscely L Go, MD,FPNA,DPBP principal investigator
Jose R. Reyes Memorial Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MINGO in people with X-Linked Dystonia Parkinsonism, run by Sunshine Care Foundation at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale. (time frame: after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.