Maternal and Child HealthPhase 1/2RCTNCT06354621
Impact of Vitamin D Supplementation on Fetomaternal Outcomes in LTBI Pregnant Females
A Phase 1/2 study testing Vitamin-D supplementation in people with Maternal and Child Health, run by University of the Punjab at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal and Child Health
- What is being tested?
- Vitamin-D supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 20 Mar 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant females aged 18-35 years, already enrolled for delivery in the specified setting coming regularly for prenatal checkups with positive tuberculin skin test
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Maternal and Child Health
- Being tested
- Vitamin-D supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin-D supplementationDietary supplement
Participants receiving a daily dose of vitamin D supplementation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Vitamin-D supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Eclampsia (Maternal Outcome)
Incidence of Pre-eclampsia (percentage of Females having proteinuria on urine dip test with blood pressure > 140/90 mmHg)
Measured: 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)
Measured: 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)
Measured: Three months
Low Birth Weight (Foetal Outcome)
Incidence of low birth weight babies (percentage of neonates weighing <2.5kg)
Measured: One month
Pre-Term delivery (Foetal Outcome)
Incidence of pre-term delivery (percentage of live births before 37 completed gestation weeks)
Measured: 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.)
Measured: One month
Secondary outcomes (1)
Improvement in maternal vitamin-D levels
To determine whether the baseline vitamin D levels are modified by vitamin D supplementation. (Post intervention mean vitamin-D levels in ng/dl)
Measured: Two-Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Sep 2023
- Primary completion28 Feb 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal and Child HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Punjab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, USMAN JAVED IQBAL, University of the Punjab
- Investigators
- Rubeena Zakar, PhD, Study director, University of the Punjab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354621
- Sponsor's protocol ID
- D/185/FIMS
- Acronym
- RCT
- Status last verified
- Apr 2024
- First submitted
- 10 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21706518
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D Supplementation on Fetomaternal Outcomes in Pregnant Females With Latent Tuberculosis Infection: A Randomized Controlled Trial in Lahore-Punjab
- ClinicalTrials.gov ID
- NCT06354621
- Acronym / sponsor ID
- RCT / D/185/FIMS
- Conditions
- Maternal and Child Health
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of the PunjabUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group-A (Control Group) | No intervention | –Participants receiving standard antenatal care without having any vitamin-D supplementation/intervention |
| Group-B (2000IU/day) | Experimental | Dietary Supplement: Vitamin-D supplementationParticipants receiving 2000IU/day of Vitamin-D supplementation, in addition to having standard antenatal care |
| Group-C (4000IU/day) | Experimental | Dietary Supplement: Vitamin-D supplementationParticipants receiving 4000IU/day of Vitamin-D supplementation, in addition to having standard antenatal care |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant females aged 18-35 years, already enrolled for delivery in the specified setting coming regularly for prenatal checkups with positive tuberculin skin test
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin-D supplementationParticipants receiving a daily dose of vitamin D supplementation | Dietary supplement | Group-B (2000IU/day), Group-C (4000IU/day) |
Primary outcome
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)
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)
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)
Low Birth Weight (Foetal Outcome)
Time frame: One month
Incidence of low birth weight babies (percentage of neonates weighing <2.5kg)
Pre-Term delivery (Foetal Outcome)
Time frame: One month
Incidence of pre-term delivery (percentage of live births before 37 completed gestation weeks)
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.)
1 secondary outcome
Improvement in maternal vitamin-D levels
Time frame: Two-Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Results publication: PubMed 21706518Hollis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubeena Zakar, PhD study director
University of the Punjab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamin-D supplementation in people with Maternal and Child Health, run by University of the Punjab at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-Eclampsia (Maternal Outcome) (time frame: Three months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06354621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.