Vitamin D3 Supplementation Regimens and Preeclampsia Risk (VitD-PE-RCT)
Effect of Different Dosages of Vitamin D3 Supplementation on the Risk of Preeclampsia in Pregnant Women With Vitamin D Deficiency
This study is a randomized controlled trial with two parallel groups connected at Al-Thawra Modern General Hospital in Sana'a, Yemen.
It aims to compara the effect of two different vitamin D3 supplementation regimens during pregnancy on the risk of pre-eclampsia among women with confirmed vitamin D deficiency.
Pregnant women attending antenatal care and diagnosed with vitamin D deficiency will be screened for eligibility. Eligible participants will be randomly assigned to one of two intervention groups:one group receiving vitamin D3 50,000 IU every two weeks and the other group receiving vitamin D3 5,000 IU weekly,in addition to standard antenatal care.
The study will include singleton pregnancies between 8_18 weeks of gestation with serum 25-hydroxyvitamin D level below 25 ng /mL . Women with chronic conditions that may affect pregnancy outcomes or vitamin D metabolism will be excluded. Participants will be followed throughout pregnancy to assess the development of pre-eclampsia and other maternal and fetal outcomes.
調査の概要
詳細な説明
Vitamin D deficiency during pregnancy has been associated with advers maternal and neonatal outcomes, including an increased risk of preeclampsia.However,the optimal dosage regimen of vitamin D3 supplementation in deficient pregnant women remains uncertain.
This randomized controlled trial will be conducted at Al-Thawra Modern General Hospital in Sana'a, Yemen, and will include pregnant women with confirmed vitamin D deficiency in early pregnancy. Participants will be randomly assigned to one of two vitamin D3 supplementation regimens and followed throughout pregnancy.
The study aims to compare the effectiveness of two different vitamin D3 dosing scheduales in reducing the incidence of preeclampsia.Maternal vitamin D status and pregnancy outcomes will be assessed as secondary measures to evaluate the overall impact of supplementation.
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：Amany Omer Taib, MBBS
- 電話番号：+967775851225
- メール：a.taib@su.edu.ye
研究場所
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Maeen District
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Sanaa、Maeen District、イエメン
- 募集
- Faculty of Medicine and Health Sciences, Sana'a University
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コンタクト：
- Amany Omer Taib, MBBS
- 電話番号：+967775851225
- メール：a.taib@su.edu.ye
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-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Singleton pregnancy
- Pregnant women between 8 and 18 weeks of gestation
- Serum 25-hydroxyvitamin D [25(OH)D] level < 25 ng/mL
- Willing and able to provide written informed consent
- Planning to receive ongoing antenatal care and deliver at Al-Thawra Modern General Hospital.
Exclusion Criteria:
- Uncontrolled chronic hypertension
- Current use of vitamin D supplementation before enrollment
- Severe chronic kidney disease
- Pre-existing diabetes mellitus
- Autoimmune or immunological disorders
- Known fetal congenital anomalies
- Primary hyperparathyroidism
- Thyroid disease
- Use of medications that affect vitamin D or calcium metabolism
- Inability or unwillingness to comply with the study protocol or follow-up schedule
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：防止
- 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 |
|---|---|
|
実験的：Arm 1: Vitamin D3 50,000 IU every 2 weeks
Participants in this arm will receive oral vitamin D3 supplementation at a dose of 50,000 IU every 2 weekly in addition to routine antenatal care.
Supplementation will continue from enrollment until delivery, and participants will be monitored throughout pregnancy for the development of preeclampsia and other maternal and neonatal outcomes.
|
Arm 1: Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 50,000 IU every two weeks according to their randomized group assignment.
Oral vitamin D3 supplementation administered during pregnancy.
Participants will receive : 5,000 IU every week according to their randomized group assignment.
|
|
実験的：Arm 2 : Vitamin D3 5,000 IU every week
Participants in this arm will receive oral vitamin D3 supplementation at a dose of 5,000 IU once weekly in addition to routine antenatal care.
Supplementation will continue from enrollment until delivery, and participants will be monitored throughout pregnancy for the development of preeclampsia and other maternal and neonatal outcomes.
|
Arm 1: Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 50,000 IU every two weeks according to their randomized group assignment.
Oral vitamin D3 supplementation administered during pregnancy.
Participants will receive : 5,000 IU every week according to their randomized group assignment.
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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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Incidence of Pre-eclampsia events
時間枠：From 20 weeks of gestation until delivery
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Occurance of preeclampsia during pregnancy , diagnosed according standared clinical criteria including new onset hypertention after 20weeks of gestation with proteinuria or other feature of maternal organ dysfunction.
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From 20 weeks of gestation until delivery
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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 |
|---|---|---|
|
Severity of Preeclampsia
時間枠：At diagnosis of preeclampsia until delivery
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Description Severity of preeclampsia assessed by the need for preterm delivery, maternal intensive care unit admission, or other severe maternal complications.
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At diagnosis of preeclampsia until delivery
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Gestational Age at Onset of Preeclampsia
時間枠：At first diagnosis of preeclampsia
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Gestational age in weeks at the time of first diagnosis of preeclampsia.
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At first diagnosis of preeclampsia
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Occurrence of Severe Maternal Complications
時間枠：From enrollment until delivery
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Occurrence of HELLP syndrome, eclampsia, or placental abruption during pregnancy
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From enrollment until delivery
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Incidence of Gestational Diabetes Mellitus
時間枠：From enrollment until delivery]
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Occurrence of gestational diabetes diagnosed according to standard clinical criteria.
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From enrollment until delivery]
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Incidence of Gestational Hypertension
時間枠：From enrollment until delivery
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Occurrence of gestational hypertension diagnosed according to standard clinical criteria.
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From enrollment until delivery
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Maternal Mortality
時間枠：From enrollment until 42 days postpartum
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Death of a participant during pregnancy or within 42 days after termination of pregnancy.
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From enrollment until 42 days postpartum
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Incidence of Low Birth Weight
時間枠：At birth
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Proportion of newborns with birth weight less than 2500 grams.
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At birth
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Incidence of Preterm Birth
時間枠：At delivery
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Delivery occurring before 37 completed weeks of gestation.
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At delivery
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Neonatal Intensive Care Admission
時間枠：At birth
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Admission of the newborn to a neonatal intensive care unit.
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At birth
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Mean Birth Weight
時間枠：At birth
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Birth weight of newborns measured in grams.
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At birth
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Neonatal Mortality
時間枠：From birth to 28 days of life
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Death of a live-born infant during the neonatal period.
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From birth to 28 days of life
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Amany Omer Taib, MBBS、Faculty of Medicine and Health Sciences, Sana'a University
研究記録日
主要日程の研究
研究開始 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- VitD-PE-2024
- (26)-12-8 (その他の識別子：Research Ethics Committee-Sana'a University)
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
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
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