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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ammara Suleman
- 電話番号：+92 321 5279502
- メール：shazibnawaz2016@gmail.com
研究場所
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Islamabad、パキスタン
- Pakistan Air Force (PAF) Hospital Islamabad
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Daily Iron
One ferrous sulfate 325 mg tablet (approximately 65 mg elemental iron) once daily for four weeks.
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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.
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実験的：Alternate-Day Iron
Two ferrous sulfate 325 mg tablets (approximately 130 mg elemental iron) every other day for four weeks.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in hemoglobin from baseline to Week 4
時間枠：Baseline and Week 4
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Mean within-participant change in hemoglobin concentration (g/dL), measured at baseline and at Week 4, compared between the daily and alternate-day arms.
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Baseline and Week 4
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in serum ferritin from baseline to Week 4
時間枠：Baseline and Week 4
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Mean within-participant change in serum ferritin concentration (ng/mL) from baseline to Week 4, compared between groups.
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Baseline and Week 4
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Treatment adherence
時間枠：Through Week 4
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Proportion of participants taking at least 80 percent of prescribed doses, determined by pill count cross-checked against patient dose diaries.
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Through Week 4
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Frequency of gastrointestinal side effects
時間枠：Through Week 4
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Proportion of participants reporting any gastrointestinal side effect (nausea, vomiting, constipation, metallic taste, or abdominal discomfort) recorded using a structured checklist.
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Through Week 4
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Severity of gastrointestinal side effects
時間枠：Through Week 4
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Severity of reported gastrointestinal side effects graded as mild, moderate, or severe on a structured checklist.
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Through Week 4
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協力者と研究者
捜査官
- 主任研究者：Ammara Suleman, MBBS、Pakistan Air Force (PAF) Hospital Islamabad
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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