Liposomal Iron 30 mg Supplement in Non-anemic Pregnant Females

Launched by ORCHIDIA PHARMACEUTICAL INDUSTRIES · Oct 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a daily liposomal iron supplement on pregnant women who are not anemic but may still benefit from additional iron during their second trimester. The main goal is to see if taking 30 mg of this special form of iron will help maintain healthy hemoglobin levels, which is important for both the mother and baby. Non-anemic pregnant women aged 18 to 45 with low-risk, single pregnancies, who are between 14 and 16 weeks pregnant, may be eligible to participate.

If you join the study, you will take the iron supplement daily for 90 days and visit your healthcare provider for check-ups at 30, 60, and 90 days. During these visits, you'll answer questions about how well you follow the supplement routine and any side effects you might experience. Blood tests will also be done to check your hemoglobin and ferritin levels, which indicate your iron stores. The study aims to understand how well this type of iron works compared to traditional supplements and whether it’s easier for women to take. The trial is set to start recruiting participants in November 2024 and wrap up by July 2025.

Gender

FEMALE

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.