CClinicalTrials.gg
CompletedNCT04874285Updated Nov 3, 2023

Use of Dietary Supplements in Patients at Risk of Abortion Treated With Progesterone.

An interventional study of HA in Pregnancy, High Risk, sponsored by Lo.Li.Pharma s.r.l. Completed at 1 site in Italy. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-03.

Sponsored by Lo.Li.Pharma s.r.l · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

The trial aims to investigate the effect of supplementation with hyaluronic acid, alpha-lipoic acid, magnesium, vitamin D and vitamin B6 in progesterone-treated pregnant women with risk factors for abortion.

02

Conditions studied

  • Pregnancy, High Risk
03

In context

Lead sponsor

Lo.Li.Pharma s.r.l is the lead sponsor of 30 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Women with risk factor for abortion (sub-chorionic hematoma during gestation or ART procedures)

Exclusion criteria

Exclusion Criteria:

  • Other pregnancy-related conditions
  • Diabetes or hypertension
  • Concomitant pharmacological therapies (anticoagulant or antihypertensive)
  • Use of tocolytic drugs two months prior to enrollment
  • Association with hypoglycemic drugs
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • No intervention
    control group

    Women with risk factors for abortion, treated with progesterone

  • Experimental
    study group

    Women with risk factors for abortion, treated with progesterone and a dietary supplement containing hyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6

    Dietary Supplement: HA

Interventions

  • Dietary supplementHA

    hyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6

06

What researchers measure

Primary outcomes

  1. reduction of the abortion rate

    rate of abortion

    Time frame: 1 day (single time-point before week 20 of gestation)

07

Study locations

1 site
  • Clinica Alma Res
    Rome, 00198, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04874285
Lead sponsor
Lo.Li.Pharma s.r.l
Responsible party
Sponsor
First posted
May 5, 2021
Start date
May 3, 2021
Primary completion
May 30, 2022
Completion
May 11, 2023
Last update
Nov 3, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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