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

• Sponsor: University of Modena and Reggio Emilia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03952533
• Collaborator: (none)
• Enrollment: 122
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.9
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Monocentric open label randomized controlled studyMonocentric 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
• Actual Study Start Date: May 5, 2019
• Actual Primary Completion Date: Sep 25, 2020
• Actual Study Completion Date: Jun 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Cervical shortening [from 11-14 weeks to 19-21 weeks of Gestational age]

   Cervical shortening detected by the transvaginal ultrasound (TVS)

2. Rate of Short Cervix [at 19-21 weeks of Gestational age]

   Rate of cervical length < 25mm at the TVS exam

3. Rate of Preterm birth [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 [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 [from 11-14 weeks to 37 weeks of Gestational age]

   Maternal need for hospital admission for threatened preterm labor

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 41 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Modena and Reggio Emilia	Modena	Mo	Italy	41100

Sponsors and Collaborators

• University of Modena and Reggio Emilia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Fabio Facchinetti, Full Professor, University of Modena and Reggio Emilia
• ClinicalTrials.gov Identifier: NCT03952533
• Other Study ID Numbers: 0013213/19
• First Posted: May 16, 2019
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prof. Fabio Facchinetti, Full Professor, University of Modena and Reggio Emilia: alpha-lipoic Acid; vitamin D; cervical shortening; pretermbirth; food supplement
• Additional relevant MeSH terms: Premature Birth

Study Results

No Results Posted as of May 18, 2022