Pre-eclampsiaPhase 4NCT07288801
Vitamin D for Preventing Recurrent Preeclampsia in Pregnant Women
A Phase 4 study testing Vitamin D in people with Pre-eclampsia and Pregnancy, run by Nishtar Medical University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to find out whether giving vitamin D to pregnant women who had pre-eclampsia in a previous pregnancy helps prevent the condition from coming back. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Pre-eclampsia, Pregnancy, Vitamin D
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Aug 2025to 8 Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age ≥ 20-weeks (on LMP method) ' - Past medical history of pre-eclampsia
Who cannot join
- Pre-existing hypertension, cardiac diseases, renal disease, thyrotoxicosis (on history and medical record)
- Women presenting with intra-uterine death of the fetus.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Nishtar Medical University and Hospital
Multan, Punjab Province, 60000
Tehseen A Principal Investigator, MBBS, +92 303 7832417, tehseenaslam451@gmail.com
Mehnaz K Professor, FCPS, +92 333 6131713, mehnazkhakwani713@gmail.com
About this study
Official title: Role of Vitamin D in Prevention of Preeclampsia Recurrence in Pregnant Women With Previous History of Preeclampsia: A Randomized Controlled Trial
The goal of this clinical trial is to find out whether giving vitamin D to pregnant women who had pre-eclampsia in a previous pregnancy helps prevent the condition from coming back. The main question it aims to answer is:
Does vitamin D supplementation reduce the chance of pre-eclampsia recurring in pregnant women with a history of pre-eclampsia?
Read more
To answer this question, pregnant women attending the antenatal clinic at the Department of Obstetrics and Gynaecology, Nishtar Hospital Multan will be invited to join the study.
Participants will be randomly assigned to two equal groups:
- Vitamin D group: will take 4,000 IU of oral vitamin D until 36 weeks of gestation.
- Placebo group: will receive a pill identical in appearance, taste, and consistency but without vitamin D.
While on the study medication, each woman will visit the clinic every two weeks. At each visit, her blood pressure will be measured, and if it is 140/90 mmHg or higher, a urine test will check for protein to identify pre-eclampsia as per hospital protocol. Any diagnosis of pre-eclampsia will lead to standard care, and the outcome will be recorded.
At the end, researchers will compare how many women in each group developed recurrent pre-eclampsia.
This study will help answer whether vitamin D supplementation can safely reduce the risk of pre-eclampsia returning in women with a prior history - a question important for improving pregnancy outcomes and maternal health.
- Conditions
- Pre-eclampsia, Pregnancy, Vitamin D
- Being tested
- Vitamin D, Placebo and standard of care
- Keywords
- pre-eclampsia, pregnancy, recurrence, Vitamin D
- Medical subject headings
- Pre-Eclampsia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
4000 IU of vitamin D will be given orally, once daily till 36-weeks of gestation
Placebo and standard of careDrug
Also called Placebo
Look, smell and taste alike oil emulsion drops, same number, till 36-weeks of gestation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Oral supplementation with high dose vitamin D Receives: Drug: Vitamin D |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo and standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-eclampsia
Pregnant women, ≥ 20-weeks of gestation (on LMP method) having blood pressure of ≥140/90 mm of Hg plus protein (+1 or higher) in spot urine examination by dipstick method
Measured: From enrollment till 36 completed weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start9 Aug 2025
- Primary completion8 Feb 2026 (estimated)
- Study completion8 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-eclampsiaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tehseen Aslam, Nishtar Medical University
- Investigators
- Mehnaz K Professor, FCPS, Study chair, Nishtar Medical University and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288801
- Sponsor's protocol ID
- U1111-1332-4347
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Vitamin D in Prevention of Preeclampsia Recurrence in Pregnant Women With Previous History of Preeclampsia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07288801
- Acronym / sponsor ID
- U1111-1332-4347
- Conditions
- Pre-eclampsia, Pregnancy, Vitamin D
- Keywords
- pre-eclampsia, pregnancy, recurrence, Vitamin D
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 9 Aug 2025 (actual)
- Primary completion
- 8 Feb 2026 (estimated)
- Study completion
- 8 Feb 2026 (estimated)
- First posted
- 17 Dec 2025 (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 clinical trial is to find out whether giving vitamin D to pregnant women who had pre-eclampsia in a previous pregnancy helps prevent the condition from coming back. The main question it aims to answer is:
Does vitamin D supplementation reduce the chance of pre-eclampsia recurring in pregnant women with a history of pre-eclampsia?
To answer this question, pregnant women attending the antenatal clinic at the Department of Obstetrics and Gynaecology, Nishtar Hospital Multan will be invited to join the study.
Participants will be randomly assigned to two equal groups:
- Vitamin D group: will take 4,000 IU of oral vitamin D until 36 weeks of gestation.
- Placebo group: will receive a pill identical in appearance, taste, and consistency but without vitamin D.
While on the study medication, each woman will visit the clinic every two weeks. At each visit, her blood pressure will be measured, and if it is 140/90 mmHg or higher, a urine test will check for protein to identify pre-eclampsia as per hospital protocol. Any diagnosis of pre-eclampsia will lead to standard care, and the outcome will be recorded.
At the end, researchers will compare how many women in each group developed recurrent pre-eclampsia.
This study will help answer whether vitamin D supplementation can safely reduce the risk of pre-eclampsia returning in women with a prior history - a question important for improving pregnancy outcomes and maternal health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Vitamin DOral supplementation with high dose vitamin D |
| Placebo | Placebo comparator | Drug: Placebo and standard of carePlacebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Gestational age ≥ 20-weeks (on LMP method) ' - Past medical history of pre-eclampsia
Key exclusion criteria (2 listed)
- Pre-existing hypertension, cardiac diseases, renal disease, thyrotoxicosis (on history and medical record)
- Women presenting with intra-uterine death of the fetus.
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 D4000 IU of vitamin D will be given orally, once daily till 36-weeks of gestation | Drug | Intervention |
| Placebo and standard of careAlso: PlaceboLook, smell and taste alike oil emulsion drops, same number, till 36-weeks of gestation | Drug | Placebo |
Primary outcome
Pre-eclampsia
Time frame: From enrollment till 36 completed weeks of gestation
Pregnant women, ≥ 20-weeks of gestation (on LMP method) having blood pressure of ≥140/90 mm of Hg plus protein (+1 or higher) in spot urine examination by dipstick method
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Pre-eclampsia
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Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Mehnaz K Professor, FCPS study chair
Nishtar Medical University and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Pre-eclampsia and Pregnancy, run by Nishtar Medical University 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 2 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tehseen A Principal Investigator, MBBS (+92 303 7832417, tehseenaslam451@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-eclampsia (time frame: From enrollment till 36 completed weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2025.