Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2026-03-20 @ 2:47 PM
Study NCT ID:
NCT02016495
Status:
COMPLETED
Last Update Posted:
2013-12-20
First Post:
2013-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Magnesium and Alpha Lipoic Acid Supplementation in Reducing Premature Uterine Contractions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008274', 'term': 'Magnesium'}, {'id': 'D008063', 'term': 'Thioctic Acid'}], 'ancestors': [{'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-12-16', 'studyFirstSubmitDate': '2013-12-16', 'studyFirstSubmitQcDate': '2013-12-16', 'lastUpdatePostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of women with sporadic episodes of preterm uterine contraction', 'timeFrame': 'From baseline (beginning of the treatment) until delivery'}, {'measure': 'Number of women with frequent and persistent episodes of preterm uterine contractions associated with pain', 'timeFrame': 'From baseline (beginning of the treatment) until delivery'}, {'measure': 'Number of women needed for hospital admission for threatened preterm labour', 'timeFrame': 'From baseline (beginning of the treatment) until delivery'}]}, 'conditionsModule': {'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'To evaluate whether a combined supplementation of magnesium and lipoic acid is able to significantly reduce the incidence of uterine contractions and related episodes of hospitalization in pregnant women.', 'detailedDescription': 'Primary prevention of preterm labor is based on the early identification of risk factors and on appropriate treatments. Although several drugs are currently used, the identification of effective and safe agents able to improve both maternal and fetal health is still warranted.\n\nIn this study the efficacy a formulation based on magnesium and alpha-lipoic acid has been compared with placebo to evaluate the incidence of reduction of preterm delivery.\n\nThree hundred pregnant women at 14-34 weeks of gestation were enrolled and randomly divided to receive a daily single tablet containing magnesium and alpha-lipoic acid supplement or placebo until delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '41 Years', 'minimumAge': '23 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 14-34 weeks of gestation\n\nExclusion Criteria:\n\n* Preexisting diabetes mellitus\n* Systolic blood pressure \\>140mm Hg\n* Cancer\n* lupus\n* hepatitis\n* HIV/AIDS\n* Diagnosed alcohol or chemical dependency'}, 'identificationModule': {'nctId': 'NCT02016495', 'briefTitle': 'Efficacy of Magnesium and Alpha Lipoic Acid Supplementation in Reducing Premature Uterine Contractions', 'organization': {'class': 'OTHER', 'fullName': 'AGUNCO Obstetrics and Gynecology Centre'}, 'orgStudyIdInfo': {'id': 'Mg-ALA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Magnesium + Lipoic Acid', 'interventionNames': ['Dietary Supplement: Magnesium plus alpha-lipoic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Magnesium plus alpha-lipoic acid', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Magnesium + Lipoic Acid']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Naples', 'country': 'Italy', 'facility': 'Clinica Villa delle Querce', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AGUNCO Obstetrics and Gynecology Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}