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Cervical ShorteningALANCT03952533

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

A study testing Dav in people with Cervical Shortening and Preterm Birth, run by University of Modena and Reggio Emilia at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 41 years, women only
Conditions the study is for
Cervical Shortening, Preterm Birth
What is being tested?
Dav
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteItaly
Study dates
5 May 2019to 1 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 41 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Nulliparous,
  • Previous History of preterm birth,
  • Age between 18 - 41 years,
  • 11-14 weeks of gestation,
  • BMI < 18 kg/m2 or ≥ 30 kg/m2,
  • Uterine myoma,
  • Hypertensive disorders either chronic or induced by the pregnancy

Who cannot join

  • PPROM,
  • Cervical dilation ≥ 1 cm

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University of Modena and Reggio Emilia

    Modena, Mo, 41100

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
Dav
Keywords
alpha-lipoic Acid, vitamin D, cervical shortening, pretermbirth, food supplement
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DavDietary supplement

    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)

Study groups in NCT03952533
Study groupRoleWhat they receive
ALAExperimentalALA 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.
Receives: Dietary Supplement: Dav
ControlNo interventionControl Group will be composed by women allocated in the "Control Group" and will not receive any supplementation but the standard care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cervical shortening

    Cervical shortening detected by the transvaginal ultrasound (TVS)

    Measured: from 11-14 weeks to 19-21 weeks of Gestational age

  2. Rate of Short Cervix

    Rate of cervical length < 25mm at the TVS exam

    Measured: at 19-21 weeks of Gestational age

  3. Rate of Preterm birth

    Number of preterm birth occurred

    Measured: from 11-14 weeks to 37 weeks of Gestational age

Secondary outcomes (2)

  1. Accesses to the ET for Threatened PTB

    Number of accesses to the ER for threatened PTB due to episodes of preterm uterine contractions and/or cervical shortening

    Measured: from 11-14 weeks to 37 weeks of Gestational age

  2. Maternal hospitalization for threatened preterm labor

    Maternal need for hospital admission for threatened preterm labor

    Measured: from 11-14 weeks to 37 weeks of Gestational age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2019
  2. Study start5 May 2019
  3. Primary completion25 Sep 2020
  4. Study completion1 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Monocentric open label randomized controlled study
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03952533
Sponsor's protocol ID
0013213/19
Acronym
ALA
Status last verified
May 2022
First submitted
14 May 2019
Last updated
18 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Publications

  • 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.

    PubMed 19664690

  • 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.

    PubMed 27515307

  • 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.

    PubMed 17334234

  • 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.

    PubMed 26765344

  • 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.

    PubMed 12796914

  • 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.

    PubMed 17666605

Questions about this trial

What is this clinical trial studying?

A study testing Dav in people with Cervical Shortening and Preterm Birth, run by University of Modena and Reggio Emilia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cervical shortening (time frame: from 11-14 weeks to 19-21 weeks of Gestational age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03952533, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.

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