Език: EN EN
← Назад към резултатите
Набира участници Фаза 4 NCT06492512

Oral Iron Supplementation on Alternate vs. Consecutive Days for Iron Deficiency Anemia in Pregnancy

Фаза 4 – наблюдение след одобрението на пазара
Заболявания: Iron-deficiency Anemia (IDA) Pregnancy

Спонсор: Southern Illinois University

Налично на: БГ
Обобщение
This will be a randomized clinical trial. Enrolled subjects will be randomized (1:1) into two study arms to receive either daily (Group 1) or alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill.
Описание
During the enrollment (baseline) visit, subjects will undergo a blood draw to assess hemoglobin, ferritin and soluble transferrin receptor (sTfR) levels to confirm current depleted iron stores and will then be randomly allocated into one of the two study arms. All ferrous sulfate (oral tablets) will be provided to patients by the investigators. All subjects will be instructed to take oral iron on an empty stomach or 1 hour after meals for better absorption, preferably with a vitamin C rich product such as orange juice. To minimize variability introduced by other potential iron sources, prenatal vitamins that have the same amount and form of iron will be provided to both study groups.
Кой може да участва
Inclusion Criteria: * Pregnant patients will be enrolled at less than 30 weeks gestational age (GA) with laboratory confirmed IDA (as defined by hemoglobin under 10.5 g/dL, as well as ferritin under 15 mcg/L) Exclusion Criteria: * Patients \<18 years old, patients who have severe IDA that requires blood transfusion or IV iron infusion, patients who have other known hemoglobinopathy (such as thalassemia or sickle cell anemia) or anemia of different mechanism (such as vitamin B12 or folate deficiency), patients with ulcerative colitis, Crohn's disease, gastric ulcers, patients who have previously undergone gastric bypass surgery, patients who experience admission for antepartum bleed, have been diagnosed with abnormal placentation (i.e., placenta previa, placenta accreta, placenta increta or percreta)
Интервенции
daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill
DRUG
alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill
DRUG
Места на провеждане 1
САЩ (1)
Southern Illinois University School of Medicine
Springfield , Illinois
Технически детайли
Статус
Набира участници
Фаза
Фаза 4
Вид изследване
INTERVENTIONAL
Пол
Само жени
Минимална възраст
18 Years
Максимална възраст
45 Years
Здрави доброволци
Не
Начална дата
27.05.2025
Крайна дата
30.07.2029
Регистрационен номер
NCT06492512
Източник
clinicaltrials.gov
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.