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

Maternal and Child Health Clinical Trial

— RCT  

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 Details — Status: Completed

Administrative data

• NCT number: NCT06354621
• Other study ID #: D/185/FIMS
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 1, 2023
• Est. completion date: March 20, 2024

Study information

• Verified date: April 2024
• Source: University of the Punjab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: March 20, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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;

Related Conditions & MeSH terms

• Maternal and Child Health

Intervention

Dietary Supplement:
• Vitamin-D supplementation
Participants receiving a daily dose of vitamin D supplementation

Locations

Country	Name	City	State
Pakistan	University of the Punjab	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of the Punjab

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. Erratum In: J Bone Mi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-Eclampsia (Maternal Outcome)	Incidence of Pre-eclampsia (percentage of Females having proteinuria on urine dip test with blood pressure > 140/90 mmHg)	Three months
Primary	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)	Three months
Primary	C/Section delivery (Maternal Outcomes)	Incidence of Caesarean delivery (% age of females having surgical delivery of baby via incision on abdomen and uterus)	Three months
Primary	Low Birth Weight (Foetal Outcome)	Incidence of low birth weight babies (percentage of neonates weighing <2.5kg)	One month
Primary	Pre-Term delivery (Foetal Outcome)	Incidence of pre-term delivery (percentage of live births before 37 completed gestation weeks)	One month
Primary	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.)	One month
Secondary	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)	Two-Three months