Study on Daily vs. Alternate Day Iron Supplements for Treating Iron Deficiency Anemia in Pregnant Women

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What is this study about?

This clinical trial is focused on studying iron deficiency anemia in pregnant women. This condition occurs when there is not enough iron in the body to produce the necessary amount of healthy red blood cells, which can lead to fatigue and other health issues. The treatment being tested in this study is Galfer 305mg Hard Capsules, which contain iron and are taken orally. The study aims to compare the effectiveness of taking iron supplements daily versus every other day in improving the health of pregnant women with iron deficiency anemia.

The purpose of the study is to determine if taking iron supplements every other day is just as effective as taking them daily. Participants will be randomly assigned to one of two groups: one group will take the iron supplement every day, while the other group will take it every other day. The study will last for four weeks, during which the participants’ blood levels will be monitored to assess the effectiveness of the treatment. The main focus will be on measuring the hemoglobin levels, which indicate the amount of iron in the blood.

Throughout the study, participants will also be asked about their experiences with the treatment, including any side effects they may encounter. The study will also look at other health outcomes related to pregnancy and delivery. By the end of the study, researchers hope to understand whether taking iron supplements every other day is a viable option for treating iron deficiency anemia in pregnancy, potentially offering a more convenient treatment schedule for expectant mothers.

1 joining the study

Upon joining the study, participants are required to provide written informed consent. This involves reading and understanding the information leaflet and consent form.

Participants must be at least 18 years old, have a good understanding of English, and be diagnosed with iron deficiency anaemia during pregnancy, with specific haemoglobin and serum ferritin levels.

2 randomization and treatment allocation

Participants are randomly assigned to one of two groups: daily or alternate day oral iron supplementation.

The treatment involves taking Galfer 305mg Hard Capsules orally. The frequency depends on the group assignment.

3 treatment period

The treatment lasts for 4 weeks. Participants in the daily group take the iron capsule every day, while those in the alternate day group take it every other day.

The aim is to compare the effectiveness of daily versus alternate day supplementation in improving haemoglobin levels.

4 assessment at 4 weeks

After 4 weeks, participants undergo an assessment to measure haemoglobin levels and other health indicators.

Compliance with the treatment is evaluated through a pill count and a questionnaire. Tolerance is assessed using a gastrointestinal symptom questionnaire.

5 obstetric and neonatal outcomes

The study also monitors obstetric and neonatal outcomes, including delivery outcomes, mode of delivery, and any postnatal interventions required.

Additional assessments include neonatal intensive care unit admissions, Apgar scores, birth weights, and haemoglobin levels at term.

Who Can Join the Study?

Must be able and willing to give written informed consent and follow the study requirements.
Must be 18 years or older.
Must have a good enough understanding of English to read the information leaflet and consent form, and communicate easily with the research team.
Must have a diagnosis of iron deficiency anemia (IDA), which means having a hemoglobin (Hb) level less than 10.5 grams per deciliter (g/dL) but not less than 7 g/dL, and a serum ferritin level less than 30 micrograms per liter (µg/L). Hemoglobin is a protein in red blood cells that carries oxygen, and serum ferritin is a measure of stored iron in the body.
Must be pregnant with only one baby (singleton pregnancy).
Must be between 14 and 34 weeks of pregnancy.
Must have a high enough level of English for informed consent and study participation.

Who Cannot Join the Study?

Participants who are not pregnant cannot join the study.
Participants who do not have iron deficiency anemia cannot join. Iron deficiency anemia is a condition where the body doesn’t have enough iron, leading to fewer healthy red blood cells.
Participants who are not within the specified age range cannot join. The age range is not specified here, but it is important for eligibility.
Participants who are male cannot join the study, as it is only for females.
Participants who are not considered part of a vulnerable population cannot join. A vulnerable population includes groups who may need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
The National Maternity Hospital	Dublin	Ireland

Trial status

Country	Status	Recruitment Start
Ireland	Not recruiting	21.04.2023

Trial locations

Investigated drugs:

Iron

Iron Supplement is used in this trial to treat iron deficiency anemia in pregnant women. The study is comparing two different schedules of taking the iron supplement: daily and every other day. The goal is to see if taking the supplement every other day is as effective as taking it daily in improving hemoglobin levels after four weeks of treatment.

Investigated diseases:

Iron Deficiency Anemia in Pregnancy – This condition occurs when a pregnant woman has insufficient iron levels, leading to a reduced number of red blood cells. Iron is crucial for producing hemoglobin, the protein in red blood cells that carries oxygen to the body’s tissues. During pregnancy, the body requires more iron to support the growing fetus and increased blood volume. If the body doesn’t get enough iron, it can result in fatigue, weakness, and pale skin. As the condition progresses, it may lead to more severe symptoms such as shortness of breath and dizziness. Managing iron levels is essential to ensure the health of both the mother and the developing baby.

Trial ID:

2024-512064-61-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Daily vs. Alternate Day Iron Supplements for Treating Iron Deficiency Anemia in Pregnant Women

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