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

May 17, 2022 updated by: Prof. Fabio Facchinetti, University of Modena and Reggio Emilia

Effects of the Supplementation of α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D to Women Presenting Risk Factor for Pre-term Birth

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Mo
      • Modena, Mo, Italy, 41100
        • University of Modena and Reggio Emilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical shortening
Time Frame: from 11-14 weeks to 19-21 weeks of Gestational age
Cervical shortening detected by the transvaginal ultrasound (TVS)
from 11-14 weeks to 19-21 weeks of Gestational age
Rate of Short Cervix
Time Frame: at 19-21 weeks of Gestational age
Rate of cervical length < 25mm at the TVS exam
at 19-21 weeks of Gestational age
Rate of Preterm birth
Time Frame: from 11-14 weeks to 37 weeks of Gestational age
Number of preterm birth occurred
from 11-14 weeks to 37 weeks of Gestational age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from 11-14 weeks to 37 weeks of Gestational age
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
from 11-14 weeks to 37 weeks of Gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Modena and Reggio Emilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2019

Primary Completion (Actual)

September 25, 2020

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

May 14, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (Actual)

May 16, 2019

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0013213/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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