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Impact of Vitamin D Supplementation on Fetomaternal Outcomes in LTBI Pregnant Females — RCT  

Maternal and Child Health Clinical Trial

Official title:
Impact of Vitamin D Supplementation on Fetomaternal Outcomes in Pregnant Females With Latent Tuberculosis Infection: A Randomized Controlled Trial in Lahore-Punjab

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06354621
Study type Interventional
Source University of the Punjab
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 1, 2023
Completion date March 20, 2024
View Details
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