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α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D and Risk Factor for Pre-term Birth (ALA)

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ClinicalTrials.gov Identifier: NCT03952533
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Fabio Facchinetti, University of Modena and Reggio Emilia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervical Shortening Preterm Birth Dietary Supplement: Dav Not Applicable

Detailed Description:

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.

These 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.

ALA 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.

Moreover, the administration of ALA, magnesium, vitamin B6 and vitamin D have been demonstrated to be safe in pregnancy.

The 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Monocentric open label randomized controlled study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of the Supplementation of α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D to Women Presenting Risk Factor for Pre-term Birth
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALA
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.
Dietary Supplement: Dav
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)

No Intervention: Control
Control Group will be composed by women allocated in the "Control Group" and will not receive any supplementation but the standard care.



Primary Outcome Measures :
  1. Cervical shortening [ Time Frame: from 11-14 weeks to 19-21 weeks of Gestational age ]
    Cervical shortening detected by the transvaginal ultrasound (TVS)

  2. Rate of Short Cervix [ Time Frame: at 19-21 weeks of Gestational age ]
    Rate of cervical length < 25mm at the TVS exam

  3. Rate of Preterm birth [ Time Frame: from 11-14 weeks to 37 weeks of Gestational age ]
    Number of preterm birth occurred


Secondary Outcome Measures :
  1. Accesses to the ET for Threatened PTB [ Time Frame: from 11-14 weeks to 37 weeks of Gestational age ]
    Number of accesses to the ER for threatened PTB due to episodes of preterm uterine contractions and/or cervical shortening

  2. Maternal hospitalization for threatened preterm labor [ Time Frame: from 11-14 weeks to 37 weeks of Gestational age ]
    Maternal need for hospital admission for threatened preterm labor



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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant Women
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Nulliparous,
  2. Previous History of preterm birth,
  3. Age between 18 - 41 years,
  4. 11-14 weeks of gestation,
  5. BMI < 18 kg/m2 or ≥ 30 kg/m2,
  6. Uterine myoma,
  7. Hypertensive disorders either chronic or induced by the pregnancy

Exclusion Criteria:

  1. PPROM,
  2. Cervical dilation ≥ 1 cm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952533


Contacts
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Contact: Fabio Facchinetti, MD 0554225334 fabio.facchinetti@unimore.it
Contact: Daniela Menichini, MSN 0554222587 daniela.menichini91@gmail.com

Locations
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Italy
University of Modena and Reggio Emilia
Modena, Mo, Italy, 41100
Sponsors and Collaborators
University of Modena and Reggio Emilia

Publications of Results:
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Responsible Party: Prof. Fabio Facchinetti, Full Professor, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT03952533     History of Changes
Other Study ID Numbers: 0013213/19
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan 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).

Personal 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.

The 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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Fabio Facchinetti, University of Modena and Reggio Emilia:
alpha-lipoic Acid
vitamin D
cervical shortening
pretermbirth
food supplement

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Vitamins
Vitamin D
Ergocalciferols
Thioctic Acid
Vitamin B 6
Pyridoxal
Pyridoxine
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents