Study on the Compensatory Mechanism of Iodine Nutrition and the Optimal Intake Level of Lactating Women
2020年8月9日 更新者：Wanqi Zhang、Tianjin Medical University
Due to the lack of direct evidence of optimal iodine intake of Chinese children, pregnant and lactating women and infants were found during the recent revision of Chinese dietary reference intakes (DRIs) of iodine in 2013 by the applicant Pro.
Zhang, and no systematical research about compensatory mechanism of iodine nutrition in lactating women was found yet.
Previous study funded by United Nations International Children's Emergency Fund (UNICEF) cooperated with the international experts on iodine and key project of national natural science foundation of China under the guidance of Pro.
Zhang, had obtained the safe intake range of iodine from children and pregnant women, more than 10 joint papers were published, which laid the foundation of population study and international cooperation.
調査の概要
詳細な説明
Studies indicate lactating women and their infants are the most vulnerable population to the adverse effects of iodine deficiency and excess, and because of the complexity of the study of lactating mothers and infants and the difficulty of sample collection, it is proposed to overcome this problem with the help of the advanced dried blood spot technique and iodine balance study method from the panel of Iodine Global Network (IGN). Investigators intend to recruit 900 late pregnant women in Tianjin, Hebei and Shandong;then establishing a dynamic cohort of breastfeeding mother-infant to 6 months after delivery to investigate the physiological compensatory mechanism of iodine nutrition in lactating women with the combination of animal experiment; On the other hand, 180 exclusively breastfeeding mother and infants within postpartum 0-6 months, will be selected to participate the iodine balance study.
Optimized method of iodine balance experiment of infants by both foreign partner and Pro. Zhang's team will be adopted to obtain the first iodine balance value of Chinese lactating women and infants,providing the direct evidence for the revision of DRIs in lactating women and infants, and guide the lactating women proper iodine supplementation to meet the requirements of both mothers and infants.
研究の種類
観察的
入学 (予想される)
600
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。
研究連絡先
- 名前：ying ye
- 電話番号：022-83336717
- メール：yeying@tmu.edu.cn
研究連絡先のバックアップ
- 名前：WanQi Zhang, doctorate
- 電話番号：022-83336595
- メール：wqzhang@tmu.edu.cn
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02101-02117
- 募集
- Boston University School of Medicine; Iodine Global Network (IGN)
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コンタクト：
- Elizabeth N Pearce
- 電話番号：617-414-1348
- メール：elizabeth.pearce@bmc.org
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Zurich、スイス
- 募集
- Swiss federal institute of Technology (ETH)
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コンタクト：
- Michael B Zimmermann
- 電話番号：+41-44-632-8657
- メール：michael.zimmermann@hest.ethz.ch
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副調査官：
- Maria Andersson
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Beijing、中国
- 募集
- Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
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コンタクト：
- ying ye
- 電話番号：022-83336717
- メール：yeying@tmu.edu.cn
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コンタクト：
- WanQi Zhang
- 電話番号：022-83336595
- メール：wqzhang@tmu.edu.cn
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Shandong、中国
- 募集
- Shandong Institute of Endemic Disease Control and Prevention
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コンタクト：
- Zhang WanQi
- 電話番号：022-83336595
- メール：wqzhang@tmu.edu.cn
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コンタクト：
- Ye ying
- 電話番号：022-83336717
- メール：yeying@tmu.edu.cn
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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
1日～40年 (子、大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Women in the third trimester (18-40 years old), lactating women (38-42 weeks of gestation) and infants (0-6 months), all from Tianjin, Hebei and Shandong
説明
Inclusion Criteria:
- Women in their third trimester:⑴Aged 18-40, who have lived in the area for 1 year;⑵Single pregnancy;⑶Those who have no special dietary habits;
- Lactating woman:⑴Breastfeeding a child;⑵Normal thyroid function during pregnancy;⑶Term delivery (38-42 weeks of gestation);
- Infants and young children:⑴0-6 months;⑵Breastfeeding;⑶Full term (38-42 weeks of gestation);⑷Normal birth weight (2500-4000g);⑸The thyroid-stimulating hormone (TSH) value of heel blood was normal;⑹Apgar score 8.
Exclusion Criteria:
- Women in their third trimester:⑴Smoking or drinking;⑵Iodized drugs or contrast agents have been used in the past year;⑶A history of thyroid disease, autoimmune disease, endocrine disease, heart disease, chronic disease or family hereditary disease, etc;
- Lactating woman:⑴A history of thyroid disease, autoimmune disease, endocrine disease, heart disease, chronic disease or family hereditary disease, etc;
- Infants and young children:⑴Have pathological jaundice, autoimmune disease, congenital heart disease and other diseases.
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
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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Disposable random urine
時間枠：baseline
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μg/L
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baseline
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Venous blood
時間枠：baseline
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μg/L
|
baseline
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Water iodine intake
時間枠：baseline
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μg/day
|
baseline
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Salt iodine concentration
時間枠：baseline
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μg/day
|
baseline
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Colostrum
時間枠：1 week
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μg/L
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1 week
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Mother and child urine randomly at one time
時間枠：1 week
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μg/L
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1 week
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Neonatal heel blood
時間枠：1 week
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μg/L
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1 week
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Thyroglobulin(TG)
時間枠：1 week
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ug/L
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1 week
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Thyroid-stimulating hormone
時間枠：1 week
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mIU/L
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1 week
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Infant disposable random urine
時間枠：4 weeks
|
μg/L
|
4 weeks
|
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Infant disposable random urine
時間枠：24 weeks
|
μg/L
|
24 weeks
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Infant disposable random urine
時間枠：12 weeks
|
μg/L
|
12 weeks
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24 h urine
時間枠：4 weeks
|
μg/L
|
4 weeks
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24 h urine
時間枠：12 weeks
|
μg/L
|
12 weeks
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24 h urine
時間枠：24 weeks
|
μg/L
|
24 weeks
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Urinary iodine excretion
時間枠：4 weeks
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μg/day
|
4 weeks
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Urinary iodine excretion
時間枠：12 weeks
|
μg/day
|
12 weeks
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Urinary iodine excretion
時間枠：24 weeks
|
μg/day
|
24 weeks
|
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Milk output
時間枠：4 weeks
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μg/day
|
4 weeks
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Milk output
時間枠：12 weeks
|
μg/day
|
12 weeks
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Milk output
時間枠：24 weeks
|
μg/day
|
24 weeks
|
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Milk iodine excretion
時間枠：4 weeks
|
μg/day
|
4 weeks
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Milk iodine excretion
時間枠：12 weeks
|
μg/day
|
12 weeks
|
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Milk iodine excretion
時間枠：24 weeks
|
μg/day
|
24 weeks
|
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Average iodine intake
時間枠：4 weeks
|
μg/day
|
4 weeks
|
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Average iodine intake
時間枠：12 weeks
|
μg/day
|
12 weeks
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Average iodine intake
時間枠：24 weeks
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μg/day
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24 weeks
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Thyroid volume
時間枠：1 week
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cm³
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1 week
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Thyroid volume
時間枠：4 weeks
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cm³
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4 weeks
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Thyroid volume
時間枠：12 weeks
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cm³
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12 weeks
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Thyroid volume
時間枠：24 weeks
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cm³
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24 weeks
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Thyroid nodule
時間枠：1 week
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cm³
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1 week
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Thyroid nodule
時間枠：4 weeks
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cm³
|
4 weeks
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Thyroid nodule
時間枠：12 weeks
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cm³
|
12 weeks
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Thyroid nodule
時間枠：24 weeks
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cm³
|
24 weeks
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Dried blood spot(DBS)
時間枠：3 days
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μg/L
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3 days
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Dried blood spot(DBS)
時間枠：12 weeks
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μg/L
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12 weeks
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Diet iodine intake
時間枠：1 week
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μg/day
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1 week
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Fecal iodine excretion
時間枠：1 week
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μg/day
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1 week
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：ZiYun Pan、Tianjin Medical University
- 主任研究者：JianQiang Lai、Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
- 主任研究者：XueSong Wang、Shandong Institute of Endemic Disease Control and Prevention
- 主任研究者：YiFan Duan、Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
- 主任研究者：GuiJun Tan、Tianjin Medical University
- 主任研究者：Wen Chen、Tianjin Medical University
- 主任研究者：YanTing Chen、Tianjin Medical University
- 主任研究者：Min Gao、Tianjin Medical University
- スタディチェア：Michael B Zimmermann, doctorate、Swiss federal institute of Technology (ETH)
- スタディチェア：Elizabeth N Pearce, doctorate、Boston University School of Medicine; Iodine Global Network (IGN)
- スタディチェア：Maria Andersson, doctorate、Swiss federal institute of Technology (ETH); Iodine Global Network (IGN)
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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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)
2020年1月1日
一次修了 (予想される)
2021年12月31日
研究の完了 (予想される)
2024年12月31日
試験登録日
最初に提出
2020年7月21日
QC基準を満たした最初の提出物
2020年7月27日
最初の投稿 (実際)
2020年7月30日
学習記録の更新
投稿された最後の更新 (実際)
2020年8月11日
QC基準を満たした最後の更新が送信されました
2020年8月9日
最終確認日
2020年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- NSFC-8191001159
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
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。