Not Yet RecruitingNot Applicable

Liposomal Iron 30 mg Supplement in Non-anemic Pregnant Females

714 participantsStarted 2024-11-01

Plain-language summary

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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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Inclusion Criteria: * 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 * Agree to participate in the study including data collection from medical records and participation in related questionnaires. Exclusion Criteria: * 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. * History of antepartum bleeding * Refuse to sign the informed consent.

What they're measuring

Measure the change in Maternal Hemoglobin Level

Timeframe: Baseline and after 90 days of treatment

Trial details

NCT IDNCT06669052

SponsorOrchidia pharmaceutical Industries

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-05

Contact for this trial

Nada K Rezk, Medical Advisor

+201000071245 nadakamel233@gmail.com