Impact of Vitamin D Supplementation on Fetomaternal Outcomes in Pregnant Females With Latent Tuberculosis Infection: A Randomized Controlled Trial in Lahore-Punjab
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Pre-Eclampsia (Maternal Outcome)
研究概览
简要总结
The goal of this randomized controlled trial is to see the effect of vitamin D supplementation on fetomaternal outcomes in pregnant females with Latent Tuberculosis infection
The main question[s] it aims to answer are:
If Vitamin D supplementation has any impact on maternal outcomes. If Vitamin D supplementation has any impact on fetal outcomes.
详细描述
This study aims to see the impact of vitamin D supplementation on fetomaternal outcomes in pregnant females with latent tuberculosis infection. A three-arm (parallel) randomized controlled trial (RCT) will be conducted in a high-burden setting. A calculated sample of 99 (33 in each group) pregnant females with LTBI will be enrolled based on predefined inclusion criteria. Vitamin D supplementation will be given as per study protocols. Group-A (No intervention), Group-B (2000IU/day), Group-C (4000IU/day). To maintain the safety measures throughout the study all the study participants will be monitored for hypervitaminosis D. Informed consent will be obtained from all participants. The study will be conducted after approval by the ethical review board(s). The final analysis will be based on the effect of vitamin D supplementation on pre-defined fetomaternal outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant females aged 18-35 years, already enrolled for delivery in the specified setting coming regularly for prenatal checkups with positive tuberculin skin test
排除标准
- •History of active T.B
- •Use of any dietary supplement containing more than 400 IU/day (10 mcg/day) of vitamin D within the month before enrolment;
- •Presence of any confounders;
结局指标
主要结局
Pre-Eclampsia (Maternal Outcome)
时间窗: Three months
Incidence of Pre-eclampsia (percentage of Females having proteinuria on urine dip test with blood pressure \> 140/90 mmHg)
Pre-Term delivery (Foetal Outcome)
时间窗: One month
Incidence of pre-term delivery (percentage of live births before 37 completed gestation weeks)
Low Birth Weight (Foetal Outcome)
时间窗: One month
Incidence of low birth weight babies (percentage of neonates weighing \<2.5kg)
C/Section delivery (Maternal Outcomes)
时间窗: Three months
Incidence of Caesarean delivery (% age of females having surgical delivery of baby via incision on abdomen and uterus)
Gestational Diabetes Mellitus (Maternal Outcome)
时间窗: Three months
Incidence of Gestational diabetes (percentage of females having abnormal glucose intolerance i.e. fasting glucose \> 92mg/dL, after using 75g glucose load one-hour glucose \> 180mg/dL or two-hour glucose \> 153mg/dL)
Apgar Score (Foetal Outcome)
时间窗: One month
Apgar scores (The 10-point Apgar score has been used to assess the condition and prognosis of newborn infants throughout the world. Each of five easily identifiable characteristics i.e. heart rate, respiratory effort, muscle tone, reflex irritability, and color is assessed and assigned a value of 0 to 2. The total score is the sum of the five components, and a score of 7 or higher indicates that the baby's condition is good to excellent. The Apgar score is determined at one and five minutes after delivery and is therefore a rapid way to evaluate the physical condition of newborn infants. Of the two scores, the five-minute score has come to be regarded as the better predictor of survival in infancy.)
次要结局
- Improvement in maternal vitamin-D levels(Two-Three months)
研究者
USMAN JAVED IQBAL
Principal Investigator
University of the Punjab