Acute vs. Delayed Iron Therapy: Effect on Iron Status, Anemia and Cognition
The research questions to be answered by this study are:
- Is treatment with iron more effective at improving anemia if given at the time of a malaria episode or 1 month after the episode?
- Which treatment timing is associated with more malaria episodes - 1 month delayed treatment or immediate treatment at the time of malaria?
- Does timing of iron treatment affect later thinking processes and behavior?
調査の概要
詳細な説明
The study population in this study will be children who are enrolled in our ongoing study of cerebral malaria and severe malarial anemia, "Pathogenesis of cognitive/neurologic deficits in central nervous system malaria", underway in Kampala, Uganda. The pathogenesis study seeks to address the question of why children with severe malaria have later problems in thinking. The study we are now proposing will build on this study by assessing whether children with severe malaria have iron deficiency, and if they do, whether treatment with iron at the time of malaria is less effective than treatment one month later. We believe that treatment one month later may be more effective because there is data that shows that the inflammation that occurs with a malaria episode may decrease the body's ability to absorb iron in the gut and to send iron to the places it is needed, like the bone marrow and the brain. We are doing this study to see if our hypothesis about more effective iron treatment if it is delayed is correct and assessing anemia prevalence, iron status, and long-term neurobehavioral development as outcomes.
We have three study groups: children with cerebral malaria, children with severe malarial anemia, and healthy community control children. Children found to be iron deficient will be randomized to receive iron (as ferrous sulphate syrup) either immediately or at their one-month follow-up visit. At 1-, 6, and 12-month follow-up visits changes in iron and inflammation indicators will be assessed. At the 6- and 12-month visits, neurocognitive behavior will also be evaluated and compared between the immediate vs. delayed iron groups. Malaria morbidity will be assessed via home visits during the period of iron supplementation and via clinic monitoring for the duration of the study.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Kampala、ウガンダ
- Mulago Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
All children must
- Be between the ages of 18 mo and 5 y
- Reside within 20 km of study hospital
Children with cerebral malaria must have
- Coma (BCS < 3)
- P. falciparum on blood smear
- No clinical evidence or other causes of encephalopathy
Children with severe malarial anemia must have
- Hemoglobin < 5 g/dL
- Clinical symptoms of malaria
- P. falciparum on blood smear
Community control children must
- Live in same neighborhood or extended household as a child with severe malaria
- Be within one year of age as a child with severe malaria
Exclusion Criteria:
Cerebral malaria
- WBC > 10
- Positive gram stain or culture
Severe malarial anemia
- Impaired conscious on physical exam
- Seizure activity prior to or during physical exam
- Any other evidence of CNS disease
- All exclusion criteria of CM except no lumbar puncture required
Community control children
- All exclusion criteria for CM
- Any active illness, recent illness, or recovery from illness
- Chronic illness requiring medical care
- Medical abnormalities on screening history of physical exam
- CC control with a positive malaria smear will be treated but will not be excluded from the study.
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
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター:Immediate iron
Iron-deficient children will be randomized to receive iron concurrently with anti-malarial treatment or one month later (delayed iron group).
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Iron therapy will consist of a three-month course of ferrous sulphate syrup.
For children with Hb ≥ 7 g/dL, each daily dose will be based on 2 mg iron/kg body weight.
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アクティブコンパレータ:Delayed iron
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Iron therapy will consist of a three-month course of ferrous sulphate syrup.
For children with Hb ≥ 7 g/dL, each daily dose will be based on 2 mg iron/kg body weight.
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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 |
時間枠 |
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Hemoglobin change, anemia prevalence, and socioemotional behavior in the immediate iron vs. delayed iron groups
時間枠:6 months
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6 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Chandy C John, M.D.、University of Minnesota
出版物と役立つリンク
一般刊行物
- Blatt DB, Hanisch B, Co K, Datta D, Bond C, Opoka RO, Cusick SE, Michelow IC, John CC. Impact of Oxidative Stress on Risk of Death and Readmission in African Children With Severe Malaria: A Prospective Observational Study. J Infect Dis. 2022 Sep 4;226(4):714-722. doi: 10.1093/infdis/jiac234.
- Cusick SE, Opoka RO, Ssemata AS, Georgieff MK, John CC. Delayed iron improves iron status without altering malaria risk in severe malarial anemia. Am J Clin Nutr. 2020 May 1;111(5):1059-1067. doi: 10.1093/ajcn/nqaa004.
- Cusick SE, Opoka RO, Ssemata AS, Georgieff MK, John CC. Comparison of iron status 28 d after provision of antimalarial treatment with iron therapy compared with antimalarial treatment alone in Ugandan children with severe malaria. Am J Clin Nutr. 2016 Mar;103(3):919-25. doi: 10.3945/ajcn.115.117820. Epub 2016 Feb 3.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Ferrous Sulphate Syrupの臨床試験
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Swiss Federal Institute of TechnologyJomo Kenyatta University of Agriculture and Technology完了