Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT03952533
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2019-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D and Risk Factor for Pre-term Birth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Monocentric open label randomized controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2019-05-14', 'studyFirstSubmitQcDate': '2019-05-14', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cervical shortening', 'timeFrame': 'from 11-14 weeks to 19-21 weeks of Gestational age', 'description': 'Cervical shortening detected by the transvaginal ultrasound (TVS)'}, {'measure': 'Rate of Short Cervix', 'timeFrame': 'at 19-21 weeks of Gestational age', 'description': 'Rate of cervical length \\< 25mm at the TVS exam'}, {'measure': 'Rate of Preterm birth', 'timeFrame': 'from 11-14 weeks to 37 weeks of Gestational age', 'description': 'Number of preterm birth occurred'}], 'secondaryOutcomes': [{'measure': 'Accesses to the ET for Threatened PTB', 'timeFrame': 'from 11-14 weeks to 37 weeks of Gestational age', 'description': 'Number of accesses to the ER for threatened PTB due to episodes of preterm uterine contractions and/or cervical shortening'}, {'measure': 'Maternal hospitalization for threatened preterm labor', 'timeFrame': 'from 11-14 weeks to 37 weeks of Gestational age', 'description': 'Maternal need for hospital admission for threatened preterm labor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alpha-lipoic Acid', 'vitamin D', 'cervical shortening', 'pretermbirth', 'food supplement'], 'conditions': ['Cervical Shortening', 'Preterm Birth']}, 'referencesModule': {'references': [{'pmid': '19664690', 'type': 'RESULT', 'citation': 'Shay KP, Moreau RF, Smith EJ, Smith AR, Hagen TM. Alpha-lipoic acid as a dietary supplement: molecular mechanisms and therapeutic potential. Biochim Biophys Acta. 2009 Oct;1790(10):1149-60. doi: 10.1016/j.bbagen.2009.07.026. Epub 2009 Aug 4.'}, {'pmid': '27515307', 'type': 'RESULT', 'citation': 'Grandi G, Mueller M, Bersinger N, Papadia A, Nirgianakis K, Cagnacci A, McKinnon B. Progestin suppressed inflammation and cell viability of tumor necrosis factor-alpha-stimulated endometriotic stromal cells. Am J Reprod Immunol. 2016 Oct;76(4):292-8. doi: 10.1111/aji.12552. Epub 2016 Aug 12.'}, {'pmid': '17334234', 'type': 'RESULT', 'citation': 'Kim HS, Kim HJ, Park KG, Kim YN, Kwon TK, Park JY, Lee KU, Kim JG, Lee IK. Alpha-lipoic acid inhibits matrix metalloproteinase-9 expression by inhibiting NF-kappaB transcriptional activity. Exp Mol Med. 2007 Feb 28;39(1):106-13. doi: 10.1038/emm.2007.12.'}, {'pmid': '26765344', 'type': 'RESULT', 'citation': 'De-Regil LM, Palacios C, Lombardo LK, Pena-Rosas JP. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2016 Jan 14;(1):CD008873. doi: 10.1002/14651858.CD008873.pub3.'}, {'pmid': '12796914', 'type': 'RESULT', 'citation': 'Okitsu O, Mimura T, Nakayama T, Aono T. Early prediction of preterm delivery by transvaginal ultrasonography. Ultrasound Obstet Gynecol. 1992 Nov 1;2(6):402-9. doi: 10.1046/j.1469-0705.1992.02060402.x.'}, {'pmid': '17666605', 'type': 'RESULT', 'citation': 'Berghella V, Roman A, Daskalakis C, Ness A, Baxter JK. Gestational age at cervical length measurement and incidence of preterm birth. Obstet Gynecol. 2007 Aug;110(2 Pt 1):311-7. doi: 10.1097/01.AOG.0000270112.05025.1d.'}]}, 'descriptionModule': {'briefSummary': 'Effects of oral administration of a food supplement constituted by α-lipoic acid, magnesium, vitamin B6 and vitamin D in tablets of 1,2 g administered daily to women presenting risk factors for preterm birth (PTB). The aim is to reduce the rate of short cervix at 19-21 weeks of gestational age and consequently reduce the occurrence of PTB.', 'detailedDescription': 'The physiological course of pregnancy can be threatened by the onset of rhythmic and progressive uterine contractions, associated with a shortening and dilation of the cervix.\n\nThese modifications occur as a consequence of inflammatory processes that involve important changes in the extracellular matrix of connective tissues. For this reason, in the event of a threat of preterm birth, the appropriate tocolytic therapies should be associated with interventions able to counteract morphological changes in the uterine cervix. Women presenting high or low BMI, presence of uterine myomas, metrorrhagia during the first trimester and hypertensive disorders are at risk for PTB. Current management practices remain profoundly various, without a therapeutic tocolytic strategy, especially because most of the first-line tocolytic drugs used present important side effects \\[8\\]. It is to be assessed whether a supplementation during pregnancy with minerals, vitamins, anti-inflammatory and anti-oxidant agents can avoid PTB in women with risk factors.\n\nALA may interact synergistically with magnesium, vitamin B6 and vitamin D, limiting some of the main factors related to the risk of preterm delivery - probably via the inhibition of nuclear factor k beta (NF-kB)-signaling pathway - and reducing therefore the rate of uterine contractions.\n\nMoreover, the administration of ALA, magnesium, vitamin B6 and vitamin D have been demonstrated to be safe in pregnancy.\n\nThe aim of the present study is to evaluate whether pregnant women presenting risk factors for PTB, treated with a combination of ALA, magnesium, vitamin 6 and vitamin D from 11-14 weeks of gestational age, until delivery, could present a reduced rate of cervical shortening measured by transvaginal ultrasound (TVS) at 11-14 weeks and 19-21 weeks of gestational age.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '41 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant Women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Nulliparous,\n2. Previous History of preterm birth,\n3. Age between 18 - 41 years,\n4. 11-14 weeks of gestation,\n5. BMI \\< 18 kg/m2 or ≥ 30 kg/m2,\n6. Uterine myoma,\n7. Hypertensive disorders either chronic or induced by the pregnancy\n\nExclusion Criteria:\n\n1. PPROM,\n2. Cervical dilation ≥ 1 cm'}, 'identificationModule': {'nctId': 'NCT03952533', 'acronym': 'ALA', 'briefTitle': 'α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D and Risk Factor for Pre-term Birth', 'organization': {'class': 'OTHER', 'fullName': 'University of Modena and Reggio Emilia'}, 'officialTitle': 'Effects of the Supplementation of α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D to Women Presenting Risk Factor for Pre-term Birth', 'orgStudyIdInfo': {'id': '0013213/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALA', 'description': 'ALA Group will be composed of women allocated to the "Treatment Group". These women will receive 2 tablets of Alpha lipoic Acid (ALA) as Dav® food supplement 1,2 g (Dav®, Lo.Li. Pharma, Rome, Italy) daily until delivery.', 'interventionNames': ['Dietary Supplement: Dav']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control Group will be composed by women allocated in the "Control Group" and will not receive any supplementation but the standard care.'}], 'interventions': [{'name': 'Dav', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily oral administration of a food supplement constituted by α-lipoic acid, magnesium, vitamin B6 and vitamin D in tablets of 1,2 g (Dav®, Lo.Li. Pharma, Rome, Italy)', 'armGroupLabels': ['ALA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41100', 'city': 'Modena', 'state': 'Mo', 'country': 'Italy', 'facility': 'University of Modena and Reggio Emilia', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'All information required for this study in a manner strictly reserved to the norms of Good Clinical Practice (Legislative Decree 211/2003), as well as those relating to personal and sensitive data, c.d. Privacy Code (Legislative Decree 196/2003).\n\nPersonal data, including sensitive data, will be associated with a code, from which it will be impossible to trace back to its identity: only the investigating doctor will be able to link the code to his name.\n\nThe Specialist Doctor who follows the profession in the study, the people in charge of monitoring the study and the Regulatory Authorities have access to personal data, in compliance with and with the Guidelines of the Guarantor for the protection of personal data (Resolution No. 52 of 24 / 07/2008 and subsequent amendments and additions). The staff in charge of the study is in any case obliged to maintain the confidentiality of such information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Modena and Reggio Emilia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Prof. Fabio Facchinetti', 'investigatorAffiliation': 'University of Modena and Reggio Emilia'}}}}