Vitamin D Supplementation During Pregnancy and Bone Status in Children at Birth and at One Year of Age
The Effect of Different Doses of Vitamin D Supplementation During Pregnancy on Bone and Vitamin D Status in Children at Birth and at One Year Age
Vitamin D deficiency is frequently reported in pregnant women despite recommendation of daily vitamin D supplementation of 400IU/d. Recent studies have shown that in the absence of sun exposure these doses are seldom able to achieve 25(OH)D optimal serum levels.
We hypothesize that larger doses of vitamin D are needed to be supplemented to all women during pregnancy. We hypothesize that this may have advantageous effects on maternal vitamin D and bone reserve as well on offspring vitamin D and bone status at birth and possible further on.
The aim of the present study is to compare vitamin D and bone status of infants born to mothers supplemented with 400IU/d (present recommendations) and 2000IU/d vitamin D during the third trimester of pregnancy.
調査の概要
詳細な説明
This is a prospective randomized controlled study.
120 pregnant women will be recruited at 27 weeks gestation and randomized into two treatment groups; 400IU/d or 2000IU/d vitamin D supplementation from 27 weeks until delivery.
25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), urinary calcium/creatinine and serum calcium and alkaline phosphatase (ALP) levels will be assessed in mothers at 27 weeks and at delivery.
25OHD, calcium and ALP levels, and urinary calcium/creatinine will be evaluated in offspring at birth and at one year age.
Vitamin D and calcium intake and sun exposure will be evaluated in mothers and offsprings.
Quantitative ultrasound (QUS) measurement of tibia and radius will be performed to newborns and at the age of one year.
Bone status of newborns at birth and at one year age in children will be compared between the 2 groups.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Petah Tikva、イスラエル、49202
- 募集
- Schneider Children's Medical Center of Israel
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副調査官：
- Raanan Shamir, Professor
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副調査官：
- Eran Adar, MD
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副調査官：
- Moshe Hod, Professor
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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 pregnant women aged 20 to 40 years, of any parity status.
- Signed informed consent
Exclusion Criteria:
- Presence of diseases known to affect vitamin D status such as malabsorption states, liver and renal disorders, primary and tertiary hyperparathyroidism, granulomatous disorders
- Treatment with medications known to affect vitamin D status such as anticonvulsivants, glucocorticoids, antirejection medication and retroviral agents
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：処理
- 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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実験的：Larger doses of vitamin D supplementation
The subjects enrolled in this arm will be supplemented during the third trimester of pregnancy with 2000IU vitamin D per day
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Vitamin D 2000iu/ day from the 27 week of pregnancy up to delivery
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介入なし：Conventional vitamin D supplementation
Regular supplementation during pregnancy with 400IU vitamin D
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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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Bone status in offspring at the age of one year as assessed by tibial and radius quantitative ultrasound (QUS).
時間枠：Bone status in offsprings, assessed at the age of one year
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Bone status in offsprings, assessed at the age of one year
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Vitamin D status of mothers.
時間枠：At the start of intervention, at delivery and at the age of one year
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At the start of intervention, at delivery and at the age of one year
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Maternal health status.
時間枠：At the start of intervention, at delivery and at the age of one year
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At the start of intervention, at delivery and at the age of one year
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Infants' growth.
時間枠：At the start of intervention, at delivery and at the age of one year
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At the start of intervention, at delivery and at the age of one year
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Vitamin D status in infants.
時間枠：At the start of intervention, at delivery and at the age of one year
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At the start of intervention, at delivery and at the age of one year
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Safety of vitamin D supplementation doses.
時間枠：At the start of intervention, at delivery and at the age of one year
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At the start of intervention, at delivery and at the age of one year
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Corina Hartman, MD、Rabin Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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。
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