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

NCT ID: NCT06354621

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Maternal and Child Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group-A (Control Group)

Participants receiving standard antenatal care without having any vitamin-D supplementation/intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Group-B (2000IU/day)

Participants receiving 2000IU/day of Vitamin-D supplementation, in addition to having standard antenatal care

Group Type EXPERIMENTAL

Vitamin-D supplementation

Intervention Type DIETARY_SUPPLEMENT

Participants receiving a daily dose of vitamin D supplementation

Group-C (4000IU/day)

Participants receiving 4000IU/day of Vitamin-D supplementation, in addition to having standard antenatal care

Group Type EXPERIMENTAL

Vitamin-D supplementation

Intervention Type DIETARY_SUPPLEMENT

Participants receiving a daily dose of vitamin D supplementation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin-D supplementation

Participants receiving a daily dose of vitamin D supplementation

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of the Punjab

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

USMAN JAVED IQBAL

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rubeena Zakar, PhD

Role: STUDY_DIRECTOR

University of the Punjab

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of the Punjab

Lahore, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 21706518 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D/185/FIMS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pulmonary Tuberculosis and Vitamin D
NCT00507000 UNKNOWN PHASE3
The Effect of Vitamin D on Fertility
NCT03890458 COMPLETED PHASE4