Clinical trial NCT06354621: Impact of Vitamin D Supplementation on Fetomaternal Outcomes in LTBI Pregnant Females
Official title: Impact of Vitamin D Supplementation on Fetomaternal Outcomes in Pregnant Females With Latent Tuberculosis Infection: A Randomized Controlled Trial in Lahore-Punjab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Maternal and Child Health
Lead sponsor: University of the Punjab
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Pre-Eclampsia (Maternal Outcome)
timeFrame: Three months
measure: Gestational Diabetes Mellitus (Maternal Outcome)
timeFrame: Three months
measure: C/Section delivery (Maternal Outcomes)
timeFrame: Three months
measure: Low Birth Weight (Foetal Outcome)
timeFrame: One month
measure: Pre-Term delivery (Foetal Outcome)
timeFrame: One month
measure: Apgar Score (Foetal Outcome)
timeFrame: One month
Secondary outcomes:
measure: Improvement in maternal vitamin-D levels
timeFrame: Two-Three months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of the Punjab
state: Punjab
Study officials:
affiliation: University of the Punjab
name: Rubeena Zakar, PhD
role: STUDY_DIRECTOR
References:
citation: Hollis BW, Johnson D, Hulsey TC, Ebeling M, Wagner CL. Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness. J Bone Miner Res. 2011 Oct;26(10):2341-57. doi: 10.1002/jbmr.463.