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NCT Number: NCT06354621

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

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.

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Key information

Conditions

Maternal and Child Health

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of the Punjab

Lahore, Punjab Province, 54600, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Vitamin-D supplementation

Dietary Supplement

Participants receiving a daily dose of vitamin D supplementation

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. Low Birth Weight (Foetal Outcome)

    Time frame: One month

    Incidence of low birth weight babies (percentage of neonates weighing <2.5kg)

  5. Pre-Term delivery (Foetal Outcome)

    Time frame: One month

    Incidence of pre-term delivery (percentage of live births before 37 completed gestation weeks)

  6. 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.)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of the Punjab

Other

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2024
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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