Iron Absorption From a Nutritional Iron Supplement
Conventional oral iron supplements often cause gastrointestinal side effects and are limited by poor bioavailability, leaving unabsorbed iron to reach the colon. Hydrocolloid-based hydrogel matrix formulations designed for gradual iron release present a promising approach to improve iron absorption. This study evaluates fractional iron absorption (FIA) from three low-dose hydrogel formulations containing ferrous fumarate compared with ferrous fumarate without a hydrogel matrix. Test products will be administered with water, with and without a standardized breakfast. All formulations will be intrinsically labelled with stable iron isotopes ( 57Fe or 54Fe), and FIA will be determined 14 days after administration based on erythrocyte iron incorporation. In this randomized, within-subject corssover study conducted in non-anemic, iron-depleted women, each participant will receive all test conditions and serve as her own control.
調査の概要
状態
介入・治療
- ダイエットサプリメント：Iron-Enriched Hydrogel Supplement (A with breakfast)
- ダイエットサプリメント：Iron-Enriched Hydrogel Supplement (B with breakfast)
- ダイエットサプリメント：Iron-Enriched Hydrogel Supplement (A without breakfast)
- ダイエットサプリメント：Iron-Enriched Hydrogel Supplement (B without breakfast)
- ダイエットサプリメント：Iron-Enriched Hydrogel Supplement (C with breakfast)
- ダイエットサプリメント：Control (FeFum, with breakfast)
- ダイエットサプリメント：Control (FeFum, without breakfast)
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：Camarena
- 電話番号：+41446328393
- メール：seline.camarena@pharma.ethz.ch
研究場所
-
-
Canton of Zurich
-
Zurich、Canton of Zurich、スイス、8006
- 募集
- ETH Zürich, Laboratory of Clinical Biopharmacy
-
コンタクト：
- Camarena
- 電話番号：+41446328393
- メール：seline.camarena@pharma.ethz.ch
-
-
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:
- Female aged 18 to 45 years
- Plasma ferritin <30 µg/L
- Body mass index (BMI) 18.5 kg/m2 - 24.9 kg/m2.
- Body weight <65 kg.
- Signed informed consent
- Sufficient command of English (mother tongue or B2 level)
Exclusion Criteria:
- Anemia, defined as hemoglobin (Hb) <120 g/L (<12.0 g/dL).
- Elevated systemic inflammatory markers (C-reactive protein >5.0 mg/L).
- Chronic digestive, renal and/or metabolic diseases
- Chronic medications (except for contraceptives)
- Use of vitamin, mineral, or pre-/Pprobiotic supplements in the 2 weeks before or during the study
- Blood transfusion, blood donation or significant blood loss (>400ml) over the past 4 months
- Difficulty with blood withdrawal
- Pregnancy (tested in serum/urine) or intention to become pregnant during the course of the study
- Lactation
- Previous participation in a study using stable isotopes or participation in any clinical study within the last 30 days
- Participants who cannot be expected to comply with the study protocol (e.g. not available on certain study appointments)
- Inability to understand the information sheet and the informed consent form due to cognitive or language reasons
- Smoking (>1 cigarette/week)
- Vegan diet (the standardized breakfast contains plain whole milk yogurt and butter)
Special exclusion criteria for participants in the MRI imaging sub-study (n=9):
- Presence of a heart pacemaker, neurostimulator, or any other active implanted electronic device.
- Use of a hearing aid that cannot be safely removed for the MRI examination.
- Use of removable dentures that cannot be safely removed for the MRI examination.
- History of surgery on the head or heart involving implanted material that is not confirmed MRI-safe.
- Presence of metallic objects in the body (e.g. implants, magnets, metal splinters, gunshot fragments, tattoos, piercings, or surgical clips) that are not confirmed MRI-safe.
- History of metal splinter injury (e.g. ocular foreign body) or occupational exposure associated with increased risk of retained metal fragments.
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：他の
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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 |
|---|---|
|
実験的：FeHydro-A with breakfast (Condition 1)
FeHydro-A with sodium ascorbate, consumed with a standardized breakfast |
FeHydro-A (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast
他の名前：
|
|
実験的：FeHydro-B with breakfast (Condition 2)
FeHydro-B without sodium ascorbate, consumed with a standardized breakfast |
FeHydro-B (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast
他の名前：
|
|
実験的：FeHydro-A without breakfast (Condition 3)
FeHydro-A with sodium ascorbate, consumed without breakfast |
FeHydro-A (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + 300 mL Water |
|
実験的：FeHydro-B without breakfast (Condition 4)
FeHydro-B without sodium ascorbate, consumed without breakfast |
FeHydro-B (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + 300 mL Water |
|
実験的：FeHydro-C with breakfast (Condition 5)
FeHydro-C with sodium ascorbate and gum arabic, consumed with a standardized breakfast |
FeHydro-C (20 mg elemental iron as ferrous fumarate embedded in hydrogel matrix; labeled with 57Fe or 54Fe) + Standardized Breakfast |
|
アクティブコンパレータ：Control with breakfast (Condition 6)
Control ferrous fumarate, consumed with a standardized breakfast |
Control (20 mg elemental iron as ferrous fumarate without hydrogel matrix, in gelatin capsule; labeled with 57Fe or 54Fe) + Standardized Breakfast |
|
アクティブコンパレータ：Control without breakfast (Condition 7)
Control ferrous fumarate, consumed without breakfast |
Control (20 mg elemental iron as ferrous fumarate without hydrogel matrix, in gelatin capsule; labeled with 57Fe or 54Fe) + 300 mL Water |
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 |
|---|---|---|
|
Fractional Iron Absorption
時間枠：14 days after administration of each labelled test condition
|
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in red blood cells |
14 days after administration of each labelled test condition
|
協力者と研究者
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
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual participant data (IPD) will not be made publicly available to protect participant privacy and maintain confidentiality regarding proprietary formulation data. De-identified, aggregated study results and primary outcome data will be published in peer-reviewed scientific journals and made available via public study registries upon completion of the trial.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。