Iron Absorption and Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infants Iron Status (PIANO)
2021年4月21日 更新者：Isabelle Herter-Aeberli、Swiss Federal Institute of Technology
Maternal Iron Absorption and Utilization and Iron Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infant Iron Status
Overweight and obesity causes low-grade systemic inflammation, which sharply increases risk for iron deficiency.
Studies in our laboratory have shown that this is mainly the result of reduced dietary iron absorption because of increased hepcidin concentrations.
During pregnancy, women have a large increase in iron needs because of the expansion of maternal blood volume and fetal needs.
Iron deficiency anemia in infancy can impair cognitive development.
Whether maternal adiposity impairs absorption and transfer of iron to the fetus, and thereby increases risk of iron deficiency in the mother and the infant is unclear.
調査の概要
状態
完了
詳細な説明
In obese subjects, hepcidin concentrations are increased and iron absorption is believed to be reduced, leading to iron deficiency over time.
How all this will influence iron supply of the fetus in obese pregnancy has not been well investigated to date.
Even if maternal and fetal iron uptakes are regulated separately, it is unclear to what extent maternal subclinical inflammation might influence this process.
A small study by Dao et al. indicated that maternal-fetal iron transfer was impaired in obese pregnant women, possibly due to hepcidin up-regulation.
In this study, both maternal BMI as well as hepcidin were negatively correlated with cord blood iron status.
Maternal hepcidin and c-reactive protein were significantly higher and cord blood iron was significantly lower in the obese compared to the normal weight.
Hepcidin was shown to have an effect on iron transfer across the placenta in the study by Young et al.: the transfer was increased in women with undetectable hepcidin at delivery compared to those with higher levels.
As of now, clear associations between maternal BMI or maternal hepcidin concentration and fetal iron status were not shown.
研究の種類
介入
入学 (実際)
83
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Zurich、スイス、8092
- Human Nutrition Laboratory ETH Zurich
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～45年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- Pregnant women with either normal pre-pregnancy BMI (BMI 18.5 - 24.9kg/kg2) or with overweight or obesity (BMI > 27.5kg/m2) before pregnancy (assessed based on data reported by the women at their first visit at the hospital)
- 18 to 45 years old
- singleton pregnancy
- week of pregnancy 14±3
Exclusion Criteria:
- underlying malabsorption disease
- chronic illness, which influences iron absorption
- inflammatory status other than obesity
- medical problems known to affect iron homeostasis
- smoking during pregnancy
- no regular use of medication, which influences iron absorption
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：基礎科学
- 割り当て：非ランダム化
- 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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実験的：Isotopically labeled test meal week of pregnancy 20
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test meal labeled with 12 mg 57Fe
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実験的：Isotopically labeled test meal week of pregnancy 30
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test meal labeled with 12 mg 58Fe
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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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Fractional iron absorption
時間枠：week 20 of pregnancy
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The fractional iron absorption from the first test meal will be calculated based on the shift of the iron isotopic ratios in the collected blood samples 14 days after administration of the isotopically labeled meal.
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week 20 of pregnancy
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iron transfer from the mother to the fetus in cord blood/infant
時間枠：delivery
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To determine the amount of iron transferred from the mother to the fetus
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delivery
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Fractional iron absorption
時間枠：week 30 of pregnancy
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The fractional iron absorption from the second test meal will be calculated based on the shift of the iron isotopic ratios in the collected blood samples 14 days after administration of the isotopically labeled meal.
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week 30 of pregnancy
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infants iron status
時間枠：over the first six months of life
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infants iron status
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over the first six months of life
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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 plasma ferritin
時間枠：weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in plasma ferritin
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in Hepcidin
時間枠：weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in Hepcidin
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in transferrin receptor
時間枠：weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in transferrin receptor
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in hemoglobin
時間枠：weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in hemoglobin
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in c-reactive protein
時間枠：weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in c-reactive protein
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in interleukin-6
時間枠：weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in interleukin-6
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Chage in alpha-1-acid glycoprotein
時間枠：weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Chage in alpha-1-acid glycoprotein
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in retinol binding protein
時間枠：weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in retinol binding protein
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in riboflavin
時間枠：weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in riboflavin
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Assessment of children's iron needs within their first 2 years of life using an isotope dilution technique
時間枠：Follow-up blood samples at 3, 6, 12, 18, 24 months after birth
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Assessment of children's iron needs within their first 2 years of life
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Follow-up blood samples at 3, 6, 12, 18, 24 months after birth
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Assessment of recovery of mother's iron Status after pregnancy using an isotope dilution technique
時間枠：Follow-up blood samples at 3, 6, 12, 18, 24 months after delivery
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Assessment of recovery of mother's iron Status after pregnancy
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Follow-up blood samples at 3, 6, 12, 18, 24 months after delivery
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infants iron status
時間枠：over the first 24 months of life
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infants iron status
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over the first 24 months of life
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出版物と役立つリンク
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年2月1日
一次修了 (実際)
2019年4月1日
研究の完了 (実際)
2020年9月1日
試験登録日
最初に提出
2016年1月8日
QC基準を満たした最初の提出物
2016年4月18日
最初の投稿 (見積もり)
2016年4月21日
学習記録の更新
投稿された最後の更新 (実際)
2021年4月23日
QC基準を満たした最後の更新が送信されました
2021年4月21日
最終確認日
2021年4月1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。