Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT04669106
Status:
COMPLETED
Last Update Posted:
2020-12-16
First Post:
2020-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mineral and Enzyme Deficiency Diseases Associated With Nutritional Diseases in Society
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D002114', 'term': 'Calcinosis'}, {'id': 'D006130', 'term': 'Growth Disorders'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-25', 'size': 604940, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2020-12-04T04:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2020-11-26', 'studyFirstSubmitQcDate': '2020-12-10', 'lastUpdatePostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'calsium, vitamin D, zinc and ferrum serum level', 'timeFrame': 'up to 1 day', 'description': "calsium, vitamin D, zinc and ferrum serum level in the mother's blood"}, {'measure': 'lipase and amylase enzime pacreatic serum level', 'timeFrame': 'up to 1 day', 'description': "lipase and amylase enzime pacreatic serum level in the mother's blood"}, {'measure': 'dietary intake per day', 'timeFrame': 'up to 2 day', 'description': 'dietary intake per day of mother and child'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nutritional deficiency', 'macronutrient', 'mineral', 'enzyme', 'stunting'], 'conditions': ['Nutrient Deficiency']}, 'descriptionModule': {'briefSummary': 'Nutritional deficiency disease is a disease caused by nutritional deficiencies, including macronutrients and micronutrients. Macronutrient diseases are diseases caused by deficiency of protein, fat and carbohydrates. This deficiency will usually show clinical symptoms that directly affect nutritional status. This study aims to study and examine mineral intake, dietary patterns of research subjects, mineral and enzyme levels, and soil condition data. The number of research subjects to be taken was 180 subjects with 90 research subjects coming from mothers who had healthy children and 90 research subjects came from mothers who had stunted children or other nutritional disorders. The research stage will run after going through the inclusion of research subjects, namely mothers who have healthy children and mothers who have nutritionally deficient children, aged 20-40 years. The research stage consisted of two stages. The statistical analysis used is to use the ANOVA test, which will then compile a manuscript.', 'detailedDescription': 'This study aims to study and examine mineral intake, dietary patterns of research subjects, mineral and enzyme levels, and soil condition data. The number of research subjects to be taken was 180 subjects with 90 research subjects coming from mothers who had healthy children and 90 research subjects came from mothers who had stunted children or other nutritional disorders. The research stage will run after going through the inclusion of research subjects, namely mothers who have healthy children and mothers who have nutritionally deficient children, aged 20-40 years. The research stage consisted of two stages. The statistical analysis used is to use the ANOVA test, which will then compile a manuscript.\n\nThis research is a case control study, with primary data collection, is a laboratory clinical trial study on the subject of mothers who have children aged 2-3 years, aged 20-40 years. The number of research subjects to be taken was 180 subjects with 90 research subjects coming from mothers who had healthy children and 90 research subjects came from mothers who had stunted children or other nutritional disorders.\n\nThe research stage consisted of two stages, the first stage was the initial screening of the primary data of the research subjects, namely by analyzing food intake including mineral intake data, the diet of the research subjects, mineral and enzyme levels, and data on soil conditions in the area. The second stage was to analyze the relationship between the existing variables so that the most significant relationship was seen between the differences in diet, mineral content, enzyme levels, and soil content between the two groups. The statistical analysis used was to use the ANOVA test.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The number of research subjects to be taken was 180 subjects with 90 research subjects coming from mothers who had healthy children and 90 research subjects came from mothers who had stunted children or other nutritional disorders. The research stage will run after going through the inclusion of research subjects, namely mothers who have healthy children and mothers who have nutritionally deficient children, aged 20-40 years.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mothers who had healthy children\n\nExclusion Criteria:\n\n* mothers who have healthy children and mothers who have nutritionally deficient children'}, 'identificationModule': {'nctId': 'NCT04669106', 'briefTitle': 'Mineral and Enzyme Deficiency Diseases Associated With Nutritional Diseases in Society', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Sumatera Utara'}, 'officialTitle': 'Mineral and Enzyme Deficiency Diseases Associated With Nutritional Diseases in Society', 'orgStudyIdInfo': {'id': 'USumateraUtara 3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy group', 'description': '90 research subjects coming from mothers who had healthy children', 'interventionNames': ['Other: laboratory clinical trial study']}, {'label': 'Stunting group', 'description': '90 research subjects came from mothers who had stunted children or other nutritional disorders', 'interventionNames': ['Other: laboratory clinical trial study']}], 'interventions': [{'name': 'laboratory clinical trial study', 'type': 'OTHER', 'description': 'The research stage consisted of two stages, the first stage was the initial screening of the primary data of the research subjects, namely by analyzing food intake including mineral intake data, the diet of the research subjects, mineral and enzyme levels, and data on soil conditions in the area. The second stage was to analyze the relationship between the existing variables so that the most significant relationship was seen between the differences in diet, mineral content, enzyme levels, and soil content between the two groups.', 'armGroupLabels': ['Healthy group', 'Stunting group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20155', 'city': 'Medan', 'state': 'North Sumatra', 'country': 'Indonesia', 'facility': 'Faculty of Medicine Universitas Sumatera Utara', 'geoPoint': {'lat': 3.58333, 'lon': 98.66667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Sumatera Utara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'DINA KEUMALA SARI', 'investigatorAffiliation': 'Universitas Sumatera Utara'}}}}