Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-18 @ 2:48 AM
Study NCT ID:
NCT03019458
Status:
COMPLETED
Last Update Posted:
2020-04-30
First Post:
2017-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564048', 'term': 'Dystonia 3, Torsion, X-Linked'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'patrick_acuna@hotmail.com', 'phone': '+63 947 959-1851', 'title': 'Dr. Patrick Acuna', 'organization': 'Sunshine Care Foundation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "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."}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'MINGO', '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\n\nMINGO: 6 20oz sachets will be taken daily by intervention group', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 4, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'The control group is required to eat their normal diet. They are also required to keep a daily food diary.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 1, 'seriousNumAtRisk': 26, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Intolerance to taking MINGO', 'notes': 'Any intolerance to taking MINGO that caused the subject to stop taking the supplement including 1 due to vomiting, 1 due to the subjective sensation to fullness, and 2 due to the fact they did not like the taste of MINGO.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'GI symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MINGO', '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\n\nMINGO: 6 20oz sachets will be taken daily by intervention group.\n\nThere were 24 subjects who were part of the MINGO arm.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The control group is required to eat their normal diet. They are also required to keep a daily food diary. There were a total of 26 subjects who were enrolled in the Control group'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '18.86', 'groupId': 'OG000', 'lowerLimit': '17.66', 'upperLimit': '20.06'}, {'value': '18.17', 'groupId': 'OG001', 'lowerLimit': '17.24', 'upperLimit': '19.09'}]}]}, {'title': 'week 2', 'categories': [{'measurements': [{'value': '19.00', 'groupId': 'OG000', 'lowerLimit': '17.75', 'upperLimit': '20.24'}, {'value': '18.31', 'groupId': 'OG001', 'lowerLimit': '17.30', 'upperLimit': '19.31'}]}]}, {'title': 'week 4', 'categories': [{'measurements': [{'value': '19.14', 'groupId': 'OG000', 'lowerLimit': '17.91', 'upperLimit': '20.37'}, {'value': '18.27', 'groupId': 'OG001', 'lowerLimit': '17.25', 'upperLimit': '19.29'}]}]}, {'title': 'week 6', 'categories': [{'measurements': [{'value': '19.11', 'groupId': 'OG000', 'lowerLimit': '17.90', 'upperLimit': '20.33'}, {'value': '18.06', 'groupId': 'OG001', 'lowerLimit': '17.01', 'upperLimit': '19.11'}]}]}, {'title': 'week 8', 'categories': [{'measurements': [{'value': '19.15', 'groupId': 'OG000', 'lowerLimit': '17.89', 'upperLimit': '20.40'}, {'value': '18.24', 'groupId': 'OG001', 'lowerLimit': '17.24', 'upperLimit': '19.24'}]}]}, {'title': 'week 10', 'categories': [{'measurements': [{'value': '19.03', 'groupId': 'OG000', 'lowerLimit': '17.77', 'upperLimit': '20.28'}, {'value': '18.05', 'groupId': 'OG001', 'lowerLimit': '17.01', 'upperLimit': '19.10'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '19.07', 'groupId': 'OG000', 'lowerLimit': '17.83', 'upperLimit': '20.31'}, {'value': '17.95', 'groupId': 'OG001', 'lowerLimit': '16.90', 'upperLimit': '18.99'}]}]}], 'analyses': [{'pValue': '0.084', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p value was not adjusted for multiple comparisons but rather it is the priori threshold for statistical significance at p\\<0.05.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'We adjusted for baseline Eating Assessment Tool-10 (EAT-10), MGH-Swallowing Screening Test (MGH-SST), and the Burkes-Fahn-Marsden Dysonia Scale (BFM).'}], 'paramType': 'MEAN', 'timeFrame': 'after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months', '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.', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'We proposed an intention to treat analysis, so regardless of whether an XDP subject took the prescribed # of MINGO packets or not we analyzed everyone who entered the trial'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MINGO', '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\n\nMINGO: 6 20oz sachets will be taken daily by intervention group.\n\nThere were 24 subjects who were part of the MINGO arm.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The control group is required to eat their normal diet. They are also required to keep a daily food diary. There were a total of 26 subjects who were enrolled in the Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months (study close out)', 'description': 'number of deaths in both arms at the end of the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Everyone who enrolled were analyzed'}, {'type': 'SECONDARY', 'title': 'Number of Hospitalizations Secondary to Infectious Causes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MINGO', '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\n\nMINGO: 6 20oz sachets will be taken daily by intervention group'}, {'id': 'OG001', 'title': 'Control', 'description': 'The control group is required to eat their normal diet. They are also required to keep a daily food diary.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months (study close out)', 'description': 'number of hospitalizations secondary to infections in both arms at the end of the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants were analyzed'}, {'type': 'SECONDARY', 'title': "Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MINGO', '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\n\nMINGO: 6 20oz sachets will be taken daily by intervention group'}, {'id': 'OG001', 'title': 'Control', 'description': 'The control group is required to eat their normal diet. They are also required to keep a daily food diary.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '26.54', 'groupId': 'OG000', 'lowerLimit': '25.39', 'upperLimit': '27.59'}, {'value': '26.54', 'groupId': 'OG001', 'lowerLimit': '25.24', 'upperLimit': '27.84'}]}]}, {'title': 'month 1', 'categories': [{'measurements': [{'value': '26.93', 'groupId': 'OG000', 'lowerLimit': '25.86', 'upperLimit': '28.00'}, {'value': '26.58', 'groupId': 'OG001', 'lowerLimit': '25.23', 'upperLimit': '27.93'}]}]}, {'title': 'month 2', 'categories': [{'measurements': [{'value': '26.96', 'groupId': 'OG000', 'lowerLimit': '25.85', 'upperLimit': '28.07'}, {'value': '26.69', 'groupId': 'OG001', 'lowerLimit': '25.13', 'upperLimit': '28.07'}]}]}, {'title': 'month 3', 'categories': [{'measurements': [{'value': '26.69', 'groupId': 'OG000', 'lowerLimit': '25.41', 'upperLimit': '27.97'}, {'value': '26.62', 'groupId': 'OG001', 'lowerLimit': '25.03', 'upperLimit': '28.18'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After baseline measurements, the investigators will measure the MUAC evey month for 3 months', '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", 'unitOfMeasure': 'cm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the trial'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MINGO', '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\n\nMINGO: 6 20oz sachets will be taken daily by intervention group.\n\nThere were 24 subjects who were part of the MINGO arm.'}, {'id': 'FG001', 'title': 'Control', 'description': 'The control group is required to eat their normal diet. They are also required to keep a daily food diary. There were a total of 26 subjects who were enrolled in the Control group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MINGO', '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\n\nMINGO: 6 20oz sachets will be taken daily by intervention group'}, {'id': 'BG001', 'title': 'Control', 'description': 'The control group is required to eat their normal diet. They are also required to keep a daily food diary.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.2', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '56.4', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '55.4', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Philippines', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of Illness', 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '8.2', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '8.8', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '18.9', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '18.2', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '18.5', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean Upper Arm Circumference (MUAC)', 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '26.5', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '26.5', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Burkes-Fahn-Marsden (BFM)', 'classes': [{'categories': [{'measurements': [{'value': '44.1', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '40.2', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '42.1', 'spread': '3.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This is a scale that is done to score dystonia severity from 0 to 120 with higher numbers indicating worse outcome. A movement disorder specialist was the one who performed the scale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Eating Assessment Tool (EAT-10)', 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '19.9', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '19.9', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'EAT-10 is a subjective swallowing screening tool for dysphagia that ranges from 0-40 with higher scores meaning more difficulty in swallowing', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'MGH-Swallowing Screening Tool (MGH-SST)', 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '3.8', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '3.8', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'MGH SST is an objective swallowing screening tool to determine the risk of aspiration from 0-5 with 5 being the highest risk to aspiration', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-25', 'size': 278934, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-20T17:28', 'hasProtocol': True}, {'date': '2016-11-11', 'size': 148210, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-20T17:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2017-01-09', 'resultsFirstSubmitDate': '2017-12-07', 'studyFirstSubmitQcDate': '2017-01-10', 'lastUpdatePostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-20', 'studyFirstPostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', '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.'}], 'secondaryOutcomes': [{'measure': 'All Cause Mortality', 'timeFrame': '3 months (study close out)', 'description': 'number of deaths in both arms at the end of the study'}, {'measure': 'Number of Hospitalizations Secondary to Infectious Causes', 'timeFrame': '3 months (study close out)', 'description': 'number of hospitalizations secondary to infections in both arms at the end of the study'}, {'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', '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"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prospective randomized trial'], 'conditions': ['X-Linked Dystonia Parkinsonism']}, 'descriptionModule': {'briefSummary': 'To see whether MINGO, a food supplement, will be able to lessen the drastic weight loss seen among X-linked Dystonia Parkinsonism patients.', 'detailedDescription': "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.\n\nMINGO 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is above the age of 18\n* Positive Diagnosis of XDP by movement disorder specialist/fellow\n* Subject with a yes response to a "supportive home environment" in the patient\'s most recent "doctors monthly report"\n* Subject are easily accessible to passable roads and pubic transportation\n\nExclusion Criteria:\n\n* Subjects who have extreme movements that prevent staff from performing BMI or MUAC measurements\n* Subjects who have abnormal metabolic labs prior to the start of the study\n* Subjects who are taking pharmacological or medicinal supplements that may effect weight\n* Subjects who have been hospitalized within the last 2 weeks from the start of the trial\n* Subjects who have a Nasogastric tube or G-tube\n* Subjects with a history of other diseases that my effect weight (eg: hypo/hyperthyroidism)'}, 'identificationModule': {'nctId': 'NCT03019458', 'acronym': 'MINGO', 'briefTitle': 'MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sunshine Care Foundation'}, 'officialTitle': 'MINGO Supplemental Trial in X-linked Dystonia Parkinsonism Patients: A Prospective Randomized, Open-labeled, Parallel Group Trial', 'orgStudyIdInfo': {'id': 'MINGO-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MINGO', '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', 'interventionNames': ['Dietary Supplement: MINGO']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group is required to eat their normal diet. They are also required to keep a daily food diary.'}], 'interventions': [{'name': 'MINGO', 'type': 'DIETARY_SUPPLEMENT', 'description': '6 20oz sachets will be taken daily by intervention group', 'armGroupLabels': ['MINGO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5800', 'city': 'Roxas City', 'state': 'Capiz', 'country': 'Philippines', 'facility': 'Health Centrum', 'geoPoint': {'lat': 11.58528, 'lon': 122.75111}}], 'overallOfficials': [{'name': 'Criscely L Go, MD,FPNA,DPBP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jose R. Reyes Memorial Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunshine Care Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jose R. Reyes Memorial Medical Center', 'class': 'OTHER_GOV'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}