Liposomal Iron 30 mg Supplement in Non-anemic Pregnant Females

NCT06669052 | Not Yet Recruiting

• 1 other identifier: 00012098
• Study Type: observational
• Target: 714
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anemia of Pregnancy; Iron Deficiency Anemia

Keywords

30 mg liposomal irom; non-anemic pregnant females; observational study; hemoglobin level; Second trimester

Outcome Measures

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)

  Baseline and after 90 days of treatment

Secondary Outcomes (3)

• Measures change in Serum Ferritin Levels to evaluate changes in serum ferritin levels following liposomal iron supplementation.

  Baseline and after 90 days of treatment

• Assessment of Maternal Gastrointestinal Side Effects, to monitor gastrointestinal side effects associated with liposomal iron supplementation during pregnancy.

  Days 30, 60, and 90 of treatment

• Compliance Rate with Supplementation, to assess patient compliance with liposomal iron supplementation.

  At each prenatal visit (Days 30, 60, and 90)

Study Arms (1)

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.

Dietary Supplement: 30 mg liposomal iron, capsules

Interventions

30 mg liposomal iron, capsules 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

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant non-anemic females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orchidia pharmaceutical Industries: lead
• MARS-Global: collaborator

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Capsules

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Yasser S El Kassar, Prof. Dr.

  Faculty of medicine Alexandria university, obstetrics and gynecology department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nada K Rezk, Medical Advisor

CONTACT

+201000071245; nadakamel233@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 1, 2024
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-10