Impact of Vitamin D Supplementation on Fetomaternal Outcomes in Pregnant Females With Latent Tuberculosis Infection: A Randomized Controlled Trial in Lahore-Punjab
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of the Punjab
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Gestational Diabetes Mellitus (Maternal Outcome)
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •- Pregnant females aged 18-35 years, already enrolled for delivery in the specified setting coming regularly for prenatal checkups with positive tuberculin skin test
Exclusion Criteria
- •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;
Arms & Interventions
Group-A (Control Group)
Participants receiving standard antenatal care without having any vitamin-D supplementation/intervention
Group-C (4000IU/day)
Participants receiving 4000IU/day of Vitamin-D supplementation, in addition to having standard antenatal care
Intervention: Vitamin-D supplementation (Dietary Supplement)
Group-B (2000IU/day)
Participants receiving 2000IU/day of Vitamin-D supplementation, in addition to having standard antenatal care
Intervention: Vitamin-D supplementation (Dietary Supplement)
Outcomes
Primary Outcomes
Gestational Diabetes Mellitus (Maternal Outcome)
Time Frame: 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)
Pre-Eclampsia (Maternal Outcome)
Time Frame: 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)
Time Frame: One month
Incidence of pre-term delivery (percentage of live births before 37 completed gestation weeks)
Low Birth Weight (Foetal Outcome)
Time Frame: One month
Incidence of low birth weight babies (percentage of neonates weighing \<2.5kg)
C/Section delivery (Maternal Outcomes)
Time Frame: Three months
Incidence of Caesarean delivery (% age of females having surgical delivery of baby via incision on abdomen and uterus)
Apgar Score (Foetal Outcome)
Time Frame: 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.)
Secondary Outcomes
- Improvement in maternal vitamin-D levels(Two-Three months)
Investigators
USMAN JAVED IQBAL
Principal Investigator
University of the Punjab