Assessment of the Bioavailability of Iron in Iron Fortified Bouillon Cubes in Healthy Nigerian Women
The prevalence of iron deficiency anemia is a wide spread problem in Africa and iron fortification can be an effective strategy to decrease this.
In the current study adding different levels of a stabilizer to iron fortified cubes and it's effect on iron bioavailability from these cubes will be studied in the context of a Nigerian meal in women.
24 Female subjects with low serum ferritin levels will be included in the study. The study will last 64 days and subjects will be asked to consume a breakfast and lunch prepared with a bouillon cube with isotope labeled iron during 3 periods of 5 consecutive days. The absorption of iron will be evaluated after every period and compared between the cubes.
調査の概要
状態
条件
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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-
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Ile Ife、ナイジェリア
- Obafemi Owalowo University
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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:
- Healthy female Nigerian subjects;
- Age > 18 and <40 years at screening;
- Body weight <65 kg;
- Apparently healthy: no medical conditions which might affect study measurements (judged by study physician);
- With iron deficiency judged by a serum ferritin concentration of <15µg/L;
- Reported intense sporting activities ≤ 10h/w;
- Reported alcohol consumption ≤ 14 units/w;
- Willing and able to participate in the study;
- Having given a written informed consent.
Exclusion Criteria:
- Being an employee of Unilever or the Department of Family, Nutrition and Consumer Science of the Obafemi Alowolo University;
- Blood donation or significant blood loss over the past 6 months;
- Being severely anemic (hemoglobin < 8.0 g/dL)
- Reported use of any medically- or self-prescribed diet;
- Use of vitamin or mineral supplements and unwillingness to discontinue their use one week prior the study and during the study;
- Smoking or consuming tobacco in any form, and/or was smoking or consuming tobacco in any form for 6 months preceding the study and/or will be smoking or consuming tobacco in any form, during the study;
- Is pregnant or will be planning pregnancy during the study period;
- Is lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period;
- Known gastrointestinal (including helminth infection) or metabolic disorders;
- Participation in another clinical trial during the last 30 days prior to the beginning of the study;
- Symptomatic malaria (no blood smear analyses on malaria required)
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:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Low stabilizer level
Meals prepared with iron fortified cube with low stabilizer level
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Meals prepared with iron fortified cube with Low stabilizer level
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実験的:Medium stabilizer level
Meals prepared with iron fortified cube with medium stabilizer level
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Meals prepared with iron fortified cube with Medium stabilizer level
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実験的:High stabilizer level
Meals prepared with iron fortified cube with high stabilizer level
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Meals prepared with iron fortified cube with High stabilizer level
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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 |
---|---|---|
Iron isotopic composition of the blood at the end of each intervention period
時間枠:16 days
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The amount of iron isotopic label in the blood will be related to the low, medium and high stabilizer level in the cubes to determine whether a dose-response relationship exists.
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16 days
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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 |
---|---|---|
Iron isotopic composition of the blood
時間枠:1, 22, 43 and 64 days
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The amount of iron isotopic label in the blood at the end of each administration period plus 14 day incorporation time will be used to calculate the absolute Iron absorption for each stabilizer level
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1, 22, 43 and 64 days
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Funke Olumakaiye, PhD、Obafemi Awolowo University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (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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