NCT06354621

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

March 10, 2024

Last Update Submit

April 7, 2024

Conditions

Maternal and Child Health

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • Low Birth Weight (Foetal Outcome)

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

    One month

  • Pre-Term delivery (Foetal Outcome)

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

    One month

  • 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 Outcomes (1)

  • Improvement in maternal vitamin-D levels

    Two-Three months

Study Arms (3)

Group-A (Control Group)

NO INTERVENTION

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

Group-B (2000IU/day)

EXPERIMENTAL

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

Dietary Supplement: Vitamin-D supplementation

Group-C (4000IU/day)

EXPERIMENTAL

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

Dietary Supplement: Vitamin-D supplementation

Interventions

Vitamin-D supplementationDIETARY_SUPPLEMENT

Participants receiving a daily dose of vitamin D supplementation

Group-B (2000IU/day)Group-C (4000IU/day)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant females
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Pregnant females aged 18-35 years, already enrolled for delivery in the specified setting coming regularly for prenatal checkups with positive tuberculin skin test

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Punjab

Lahore, Punjab Province, 54600, Pakistan

Location

Related 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 Miner Res. 2011 Dec; 26(12):3001.

    PMID: 21706518RESULT

Study Officials

  • Rubeena Zakar, PhD

    University of the Punjab

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2024

First Posted

April 9, 2024

Study Start

September 1, 2023

Primary Completion

February 28, 2024

Study Completion

March 20, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)