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

April 7, 2024 updated by: USMAN JAVED IQBAL, University of the Punjab

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54600
        • University of the Punjab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group-A (Control Group)
Participants receiving standard antenatal care without having any vitamin-D supplementation/intervention
Experimental: Group-B (2000IU/day)
Participants receiving 2000IU/day of Vitamin-D supplementation, in addition to having standard antenatal care
Dietary supplement: Vitamin-D supplementation
Participants receiving a daily dose of vitamin D supplementation
Experimental: Group-C (4000IU/day)
Participants receiving 4000IU/day of Vitamin-D supplementation, in addition to having standard antenatal care
Dietary supplement: Vitamin-D supplementation
Participants receiving a daily dose of vitamin D supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Three months
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)
Three months
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)
Three months
Low Birth Weight (Foetal Outcome)
Time Frame: One month
Incidence of low birth weight babies (percentage of neonates weighing <2.5kg)
One month
Pre-Term delivery (Foetal Outcome)
Time Frame: One month
Incidence of pre-term delivery (percentage of live births before 37 completed gestation weeks)
One month
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.)
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in maternal vitamin-D levels
Time Frame: Two-Three months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Punjab

Investigators

  • Study Director: Rubeena Zakar, PhD, University of the Punjab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

February 28, 2024

Study Completion (Actual)

March 20, 2024

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

April 7, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D/185/FIMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Maternal and Child Health

Clinical Trials on Vitamin-D supplementation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe