Liposomal Iron 30 mg Supplement in Non-anemic Pregnant Females

NCT ID: NCT06669052

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 714 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-05-31

Brief 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.

Detailed Description

This observational, prospective study aims to evaluate the safety and efficacy of Liposomal Iron 30 mg supplement in non-anemic pregnant women during the second trimester (gestational weeks 14 to 16). Conducted at approximately 100investigative sites across Egypt, the study targets the enrollment of 714 participants.

The primary objective is to assess the impact of daily supplementation with liposomal iron over a 90-day period on maternal health. The study will monitor participants through routine prenatal visits, where data on adverse effects will be collected alongside routine hemoglobin and serum ferritin measurements.

The study will utilize a Data and Safety Monitoring Board (DSMB) to ensure oversight of participant safety and the integrity of study data. The DSMB will regularly review safety information and study progress, providing recommendations to the sponsor regarding the continuation or termination of the trial if necessary.

Statistical analyses will be performed using methods appropriate for the data collected, ensuring that the results will robustly assess the safety and efficacy of the liposomal iron supplement.

This study is designed to provide critical insights into iron supplementation for pregnant women, addressing a significant public health issue by exploring a formulation that may enhance compliance and reduce gastrointestinal side effects associated with traditional iron supplements.

Conditions

Anemia of Pregnancy; Iron Deficiency Anemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1 arm group, pregnant non-anemic females, second trimester.

Liposomal iron, capsules, 1 Capsule with food or few hours before or after taking other medication once daily. 1 arm group, Participants in this study will receive a daily oral dose of 30 mg Iron for a duration of 90 days. The liposomal formulation is designed to enhance the bioavailability of iron, potentially reducing gastrointestinal side effects.

30 mg liposomal iron, capsules

Intervention Type: DIETARY_SUPPLEMENT

a 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

Interventions

30 mg liposomal iron, capsules

a 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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

MARS-Global

OTHER

Sponsor Role: collaborator

Orchidia pharmaceutical Industries

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yasser S El Kassar, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine Alexandria university, obstetrics and gynecology department

Central Contacts

Nada K Rezk, Medical Advisor

Role: CONTACT

nadakamel233@gmail.com

+201000071245

Other Identifiers

00012098

Identifier Type: -

Identifier Source: org_study_id