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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Amany Omer Taib, MBBS
- 전화번호: +967775851225
- 이메일: a.taib@su.edu.ye
연구 장소
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Maeen District
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Sanaa, Maeen District, 예멘
- 모병
- Faculty of Medicine and Health Sciences, Sana'a University
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연락하다:
- Amany Omer Taib, MBBS
- 전화번호: +967775851225
- 이메일: a.taib@su.edu.ye
-
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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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실험적: 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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Pre-eclampsia events
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Severity of Preeclampsia
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Amany Omer Taib, MBBS, Faculty of Medicine and Health Sciences, Sana'a University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- VitD-PE-2024
- (26)-12-8 (기타 식별자: Research Ethics Committee-Sana'a University)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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