Liposomal Iron 30 mg Supplement in Non-anemic Pregnant Females
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorOrchidia pharmaceutical Industries
About this trial
Protocol Summary: Liposomal Iron Supplementation in Non-anemic Pregnant Females This observational study aims to evaluate the efficacy and safety of daily liposomal iron supplementation (30 mg) in non-anemic pregnant women during their second trimester of pregnancy. The study will focus on pregnant females aged 18-45 years with low-risk, singleton pregnancies who are non-anemic (hemoglobin ≥10.5) at 14-16 weeks gestation.
Primary Research Question:
Does daily supplementation with 30 mg liposomal iron effectively maintain maternal hemoglobin levels over 90 days? Measured by: The difference in maternal hemoglobin levels between baseline and after 90 days of treatment in women recruited at 14-16 weeks gestation.
Secondary Research Questions:
What are the effects of liposomal iron supplementation on serum ferritin levels? Measured by: Changes in serum ferritin levels between baseline and after 90 days of treatment.
What is the safety profile of liposomal iron supplementation during pregnancy? Measured by: Maternal gastrointestinal side effects monitored at each prenatal visit (day 30, 60, and 90).
What is the compliance rate with liposomal iron supplementation? Measured by: Participant-reported compliance assessed at each prenatal visit (day 30, 60, and 90).
Participants will:
Receive daily liposomal iron supplementation (30 mg) for 90 days. Attend regular prenatal visits for monitoring at days 30, 60, and 90. Complete questionnaires about compliance and any adverse effects at each visit. Undergo blood tests to measure hemoglobin and serum ferritin levels at baseline and day 90.
This multi-center study will involve 714 participants across 100 sites, with recruitment beginning in November 2024 and study completion expected by July 2025. The study's findings will contribute to understanding the role of liposomal iron supplementation in preventing iron deficiency during pregnancy and its potential advantages over traditional iron supplements in terms of tolerability and compliance.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant females; gestational age from 14 to 16 weeks Age 18-45 years
Low-risk pregnancy is defined as a pregnancy in which there is no high risk of problems or unfavorable outcomes, and the expectant mother and fetus are typically healthy
Non-anemic women at the time of recruitment (hemoglobin level not less than 10.5. Hemoglobin measured within 2 or 3 weeks of recruitment
Singleton pregnancy
Disqualifiers
Inadequate medical records
Pregnant women living in areas away from the recruitment center
Had any chronic health problem.
Women with any form of hereditary anemia including sickle cell anemia, thalassemia, and Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Trial population
This study will include non-anemic pregnant females \> 18 years old taking liposomal iron in non-anemic pregnant females as an iron supplement during 14-16 weeks of pregnancy. The study will be conducted at approximately 100 investigative sites in Egypt. Recruitment will stop when approximately 714 subjects are enrolled.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
30 mg liposomal iron, capsules
Dietary supplementa dietary supplement capsule, of mainly 30 mg liposomal iron, and Vitamin C 70mg, vitamin D3 400IU, vitamin B6 1.75 mcg, Folate 1000 mcg, b=vitamin B12 10 mcg. all in capsulated in 1 Hard gelatin capsule
Treatment groups
714 Participants
are divided into 1 treatment groupGroup A: 1 arm group, pregnant non-anemic females, second trimester.1 intervention
Trial outcomes
Primary outcomes
1
Measure the change in Maternal Hemoglobin Level
Measurement: To assess the efficacy of liposomal iron 30 mg once daily on hemoglobin levels in non-anemic pregnant females, measurement: Hemoglobin (g/dL)
Time frame
Baseline and after 90 days of treatmentSecondary outcomes
1
Measures change in Serum Ferritin Levels to evaluate changes in serum ferritin levels following liposomal iron supplementation.
Measurement: Ferritin (µg/L)
Time frame
Baseline and after 90 days of treatment2
Assessment of Maternal Gastrointestinal Side Effects, to monitor gastrointestinal side effects associated with liposomal iron supplementation during pregnancy.
Measurement: Incidence of side effects (Count of reported instances)
Time frame
Days 30, 60, and 90 of treatment3
Compliance Rate with Supplementation, to assess patient compliance with liposomal iron supplementation.
Measurement: Compliance rate (Percentage)
Time frame
At each prenatal visit (Days 30, 60, and 90)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Orchidia pharmaceutical Industries
Lead sponsor
MARS-Global
Collaborator
Source ClinicalTrials.gov
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