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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
99
Participants receiving a daily dose of vitamin D supplementation
University of the Punjab
Lahore, Punjab Province, Pakistan
Pre-Eclampsia (Maternal Outcome)
Incidence of Pre-eclampsia (percentage of Females having proteinuria on urine dip test with blood pressure \> 140/90 mmHg)
Time frame: Three months
Gestational Diabetes Mellitus (Maternal Outcome)
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)
Time frame: Three months
C/Section delivery (Maternal Outcomes)
Incidence of Caesarean delivery (% age of females having surgical delivery of baby via incision on abdomen and uterus)
Time frame: Three months
Low Birth Weight (Foetal Outcome)
Incidence of low birth weight babies (percentage of neonates weighing \<2.5kg)
Time frame: One month
Pre-Term delivery (Foetal Outcome)
Incidence of pre-term delivery (percentage of live births before 37 completed gestation weeks)
Time frame: One month
Apgar Score (Foetal Outcome)
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.)
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Time frame: One month
Improvement in maternal vitamin-D levels
To determine whether the baseline vitamin D levels are modified by vitamin D supplementation. (Post intervention mean vitamin-D levels in ng/dl)
Time frame: Two-Three months