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

University of the Punjab

Status and phase: Completed; Phase 2; Phase 1

Conditions: Maternal and Child Health

Treatments: Dietary Supplement: Vitamin-D supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT06354621

D/185/FIMS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 3 patient groups

Group-A (Control Group)

No Intervention group

Description:

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

Group-B (2000IU/day)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin-D supplementation

Group-C (4000IU/day)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin-D supplementation