Daily Versus Alternate-Day Oral Iron Therapy for Anemia in Second-Trimester Pregnancy
Daily Versus Alternate-Day Oral Iron Therapy for Anemia Correction in Second-Trimester Pregnant Patients: A Randomized Controlled Trial
연구 개요
상세 설명
Iron deficiency anemia is the leading cause of anemia in pregnancy. Although daily oral iron is standard first-line therapy, it is frequently associated with gastrointestinal side effects and poor adherence. Because hepcidin rises after an iron dose and remains elevated for 24 to 48 hours, daily dosing may reduce fractional absorption; alternate-day dosing allows hepcidin to fall between doses, potentially improving absorption and tolerance.
This single-center, prospective, randomized, parallel-group trial will recruit pregnant women (13 to 27 weeks gestation) with hemoglobin below 11 g/dL and serum ferritin below 30 ng/mL from the antenatal clinic at PAF Teaching Hospital, Islamabad. Eligible, consenting participants will be randomized 1:1 to daily ferrous sulfate (one 325 mg tablet, approximately 65 mg elemental iron, once daily) or alternate-day ferrous sulfate (two 325 mg tablets, approximately 130 mg elemental iron, every other day) for four weeks.
The primary outcome is change in hemoglobin from baseline to Week 4. Secondary outcomes are change in serum ferritin, treatment adherence (proportion taking at least 80 percent of doses, by pill count and diary), and the frequency and severity of gastrointestinal side effects. Outcome assessors (laboratory personnel) are blinded to allocation; participant blinding is not feasible given the differing dosing schedules. Planned enrollment is 184 participants (92 per group), giving 90 percent power to detect a 0.40 g/dL difference in hemoglobin change at a two-sided alpha of 0.05, assuming a standard deviation of 0.83 g/dL.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ammara Suleman
- 전화번호: +92 321 5279502
- 이메일: shazibnawaz2016@gmail.com
연구 장소
-
-
-
Islamabad, 파키스탄
- Pakistan Air Force (PAF) Hospital Islamabad
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Aged 18 to 40 years
- Pregnant women in the second trimester (13 to 27 weeks gestation)
- Hemoglobin below 11 g/dL with serum ferritin below 30 ng/mL
- Singleton pregnancy
Exclusion Criteria:
- Known congenital or acquired hemoglobin disorders (e.g., thalassemia, hemoglobinopathies)
- Chronic diseases affecting hemoglobin levels (e.g., chronic kidney disease, inflammatory disorders)
- Bleeding disorders or a history of frequent blood loss
- Gastrointestinal conditions impairing nutrient absorption (e.g., celiac disease or other malabsorption syndromes)
- Currently receiving parenteral iron
- Requiring blood transfusion
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Daily Iron
One ferrous sulfate 325 mg tablet (approximately 65 mg elemental iron) once daily for four weeks.
|
Oral ferrous sulfate 325 mg tablets (approximately 65 mg elemental iron per tablet) administered for four weeks according to the assigned dosing schedule.
All participants receive standardized counseling on administration, diet, side effects, and adherence, and are issued a dose diary.
|
|
실험적: Alternate-Day Iron
Two ferrous sulfate 325 mg tablets (approximately 130 mg elemental iron) every other day for four weeks.
|
Oral ferrous sulfate 325 mg tablets (approximately 65 mg elemental iron per tablet) administered for four weeks according to the assigned dosing schedule.
All participants receive standardized counseling on administration, diet, side effects, and adherence, and are issued a dose diary.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in hemoglobin from baseline to Week 4
기간: Baseline and Week 4
|
Mean within-participant change in hemoglobin concentration (g/dL), measured at baseline and at Week 4, compared between the daily and alternate-day arms.
|
Baseline and Week 4
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in serum ferritin from baseline to Week 4
기간: Baseline and Week 4
|
Mean within-participant change in serum ferritin concentration (ng/mL) from baseline to Week 4, compared between groups.
|
Baseline and Week 4
|
|
Treatment adherence
기간: Through Week 4
|
Proportion of participants taking at least 80 percent of prescribed doses, determined by pill count cross-checked against patient dose diaries.
|
Through Week 4
|
|
Frequency of gastrointestinal side effects
기간: Through Week 4
|
Proportion of participants reporting any gastrointestinal side effect (nausea, vomiting, constipation, metallic taste, or abdominal discomfort) recorded using a structured checklist.
|
Through Week 4
|
|
Severity of gastrointestinal side effects
기간: Through Week 4
|
Severity of reported gastrointestinal side effects graded as mild, moderate, or severe on a structured checklist.
|
Through Week 4
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ammara Suleman, MBBS, Pakistan Air Force (PAF) Hospital Islamabad
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
철 결핍 성 빈혈에 대한 임상 시험
-
Jerry Vockley, MD, PhDUltragenyx Pharmaceutical Inc더 이상 사용할 수 없음바르트 증후군 | 미토콘드리아 삼중기능 단백질 결핍 | 초장쇄 acylCoA 탈수소효소(VLCAD) 결핍증 | 카르니틴 팔미토일전이효소 결핍(CPT1, CPT2) | 장쇄 하이드록시아실-CoA 탈수소효소 결핍증 | 글리코겐 저장 장애 | 피루브산 카르복실라제 결핍증 | ACYL-CoA DEHYDROGENASE FAMILY, MEMBER 9, DEFICIENCY of미국
Ferrous Sulfate에 대한 임상 시험
-
Baylor College of MedicinePharmacosmos Therapeutics, Inc.모병
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University완전한
-
Medstar Health Research InstitutePfizer모병