Alternate Day Versus Daily Oral Iron Therapy in Adolescents With Iron Deficiency Anemia and Heavy Menstrual Bleeding: A Feasibility Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Percentage of Eligible Patients Enrolled.
研究概览
简要总结
Iron deficiency anemia affects over half of girls and young women with heavy periods and is the most common cause of anemia worldwide. Most girls with heavy periods who also have iron deficiency anemia are prescribed iron to take by mouth every day by their doctor. There are some studies showing that taking iron every other day may actually help the iron be absorbed into the bloodstream better. This study is trying to compare how taking iron every other day compares to taking iron daily for treatment of anemia.
The goal of this clinical research study is to learn which of the two methods of care will be the best way for girls and young women with iron deficiency anemia to take iron supplementation.
详细描述
The research will be conducted at the following location(s):
Baylor College of Medicine, TCH: Texas Children's Hospital, and TCH: Texas Children's Hospital Clinic.
If patient appears to qualify for the study they will sign and date this consent form, and the doctor will confirm that they are eligible for the study. The patient will complete the following procedures:
- Medical history including prior hospitalizations, lab results, medications, diet, social and family history
- Physical Examination
- Blood samples: The patient will not have any extra blood draws (pokes) for this study. However, we will ask to take about 1/2 (0.5) teaspoons (3 mL) of extra blood for an extra research test when you have follow up blood test(s) in one month.
Patient will be on the study for 24 weeks (6 months),and will receive an information sheet about how to take iron to help it absorb in the stomach and on iron-rich foods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 22 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 9 years or greater and less than age 22 years
- •Heavy menstrual bleeding, defined as a Pictorial Blood Assessment Chart (PBAC) Score >100
- •Iron deficiency anemia, defined as both hemoglobin <12 g/dL and ferritin <15 ng/mL within 7 days of enrollment.
排除标准
- •non-uterine cause of vaginal bleeding
- •chronic kidney disease
- •serology confirmed celiac disease
- •active gastrointestinal blood loss
- •active malignancy
- •inability to follow-up at Texas Children's Hospital
- •receipt of intravenous iron within 30 days prior to enrollment
- •allergy or known inability to tolerate oral iron
研究组 & 干预措施
Daily
Patients receive standard regimen of ferrous sulfate 325 mg (65 mg elemental iron) once every morning.
干预措施: Ferrous sulfate (Drug)
Alternate Day
Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning.
干预措施: Ferrous sulfate (Drug)
结局指标
主要结局
Percentage of Eligible Patients Enrolled.
时间窗: At enrollment
Percentage of eligible patients who consent to be enrolled in the study. A secure screening and enrollment log will be kept. Each screened patient will be categorized as either: ineligible, eligible but not approached, eligible and enrolled, eligible and declined. If the latter (eligible and declined), the reason for declining will also be obtained and noted in the study log.
次要结局
- Percentage of Enrolled Patients Who Agree to Continue in the Study After Randomization(At enrollment)
- Retention as Measured by Visit Follow-up Adherence(12 weeks)
- Adherence(12 week study visit)
研究者
Jacquelyn Powers, MD, MS
Assistant Professor
Baylor College of Medicine