Use of Dietary Supplements in Patients at Risk of Abortion Treated With Progesterone.
Sponsor
Lo.Li.Pharma s.r.l (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04874285
Collaborator
(none)
90
1
2
11.9
7.5
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Supplementation With Hyaluronic Acid, Alpha-lipoic Acid, Magnesium, and Vitamin D and B6 in Patients at Risk of Abortion Treated With Progesterone: a Pilot Study.
Actual Study Start Date
:
May 3, 2021
Anticipated Primary Completion Date
:
May 1, 2022
Anticipated Study Completion Date
:
May 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
hyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6
|
Outcome Measures
Primary Outcome Measures
- reduction of the abortion rate [1 day (single time-point before week 20 of gestation)]
rate of abortion
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Women with risk factor for abortion (sub-chorionic hematoma during gestation or ART procedures)
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinica Alma Res | Rome | Italy | 00198 |
Sponsors and Collaborators
- Lo.Li.Pharma s.r.l
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Lo.Li.Pharma s.r.l
ClinicalTrials.gov Identifier:
NCT04874285
Other Study ID Numbers:
- HMW-HA_ABORTION
First Posted:
May 5, 2021
Last Update Posted:
May 5, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No