PreeclampsiaPhase 4NCT07717931
Vitamin D Therapy to Prevent Recurrent Preeclampsia in High-Risk Pregnancies
A Phase 4 study testing Vitamin D (Cholecalciferol ) in people with Preeclampsia, run by CMH Multan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to determine whether vitamin D supplementation can reduce the recurrence of preeclampsia in pregnant women with a previous history of preeclampsia. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Vitamin D (Cholecalciferol )
- 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
- 1 Aug 2025to 30 Jan 2026
- Phase
- Phase 4
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women
- Singleton pregnancy (on USG)
- Gestational age ≥ 24-weeks (on LMP method) and
- Past medical history of pre-eclampsia (on medical record)
Who cannot join
- Pre-existing chronic hypertension
- Cardiac diseases (congenital or acquired)
- Renal disease
- Thyrotoxicosis (on history and medical record) and
- Intra-uterine death of the fetus.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
CMH Multan Institute of Medical Sciences
Multan, Punjab Province, 60000
About this study
Official title: Preventing Preeclampsia Recurrence in High-Risk Pregnancies Using Vitamin D Therapy: A Randomized Controlled Trial
The goal of this clinical trial is to determine whether vitamin D supplementation can reduce the recurrence of preeclampsia in pregnant women with a previous history of preeclampsia.
The main questions the study aims to answer are:
Read more
- Does daily vitamin D supplementation reduce the recurrence of preeclampsia compared with a placebo?
Researchers will randomly assign 146 eligible pregnant women to receive either vitamin D supplements or a placebo. The two groups will be compared to determine whether vitamin D lowers the risk of recurrent preeclampsia.
Participants will:
- Be randomly assigned to receive either 4000 IU oral vitamin D once daily or a matching placebo.
- Take the assigned study medication daily until 36 weeks of gestation.
- Attend follow-up visits every 2 weeks for blood pressure measurement and clinical assessment.
- Have serum vitamin D levels measured every 4 weeks to monitor for vitamin D toxicity.
- Undergo urine testing for protein if blood pressure is elevated to assess for preeclampsia.
The results of this study will help determine whether vitamin D supplementation is an effective and safe strategy for preventing recurrent preeclampsia in women at high risk.
- Conditions
- Preeclampsia
- Being tested
- Vitamin D (Cholecalciferol ), Placebo
- Keywords
- Vitamin D, Cholecalciferol, Preeclampsia Recurrence, High-Risk Pregnancy, Pregnancy-Induced Hypertension, Placebo
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (Cholecalciferol )Drug
Vitamin D 4000 IU will be administered orally once daily from enrollment until 36 weeks of gestation. They will attend follow-up visits every 2 weeks for blood pressure monitoring and clinical assessment, with serum vitamin D levels measured every 4 weeks.
PlaceboDrug
A matching placebo with the same taste, color, and consistency as vitamin D will be administered orally once daily from enrollment until 36 weeks of gestation for comparison with vitamin D supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Supplementation | Experimental | Participants randomized to this arm will receive oral vitamin D Receives: Drug: Vitamin D (Cholecalciferol ) |
| Placebo | Placebo comparator | Participants randomized to this arm will receive a matching placebo with the same taste, color, and consistency as the active treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Preeclampsia
Recurrence of preeclampsia will be defined as the development of new-onset hypertension (blood pressure ≥140/90 mmHg) and proteinuria (≥1+ on urine dipstick) at 20 weeks of gestation or later in women with a previous history of preeclampsia. Participants with elevated blood pressure will undergo urine protein testing to confirm the diagnosis.
Measured: From randomization until 36 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 posted21 Jul 2026
- Study start1 Aug 2025
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- CMH Multan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Soophiya Khan, CMH Multan Institute of Medical Sciences
- Investigators
- Nidda Y Assistant Professor, FCPS, Study chair, CMH Multan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717931
- Sponsor's protocol ID
- U1111-1343-7979
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Preeclampsia Recurrence in High-Risk Pregnancies Using Vitamin D Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07717931
- Acronym / sponsor ID
- U1111-1343-7979
- Conditions
- Preeclampsia
- Keywords
- Vitamin D, Cholecalciferol, Preeclampsia Recurrence, High-Risk Pregnancy, Pregnancy-Induced Hypertension, Placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- CMH Multan Institute of Medical SciencesOther government
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 21 Jul 2026 (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 determine whether vitamin D supplementation can reduce the recurrence of preeclampsia in pregnant women with a previous history of preeclampsia.
The main questions the study aims to answer are:
- Does daily vitamin D supplementation reduce the recurrence of preeclampsia compared with a placebo?
Researchers will randomly assign 146 eligible pregnant women to receive either vitamin D supplements or a placebo. The two groups will be compared to determine whether vitamin D lowers the risk of recurrent preeclampsia.
Participants will:
- Be randomly assigned to receive either 4000 IU oral vitamin D once daily or a matching placebo.
- Take the assigned study medication daily until 36 weeks of gestation.
- Attend follow-up visits every 2 weeks for blood pressure measurement and clinical assessment.
- Have serum vitamin D levels measured every 4 weeks to monitor for vitamin D toxicity.
- Undergo urine testing for protein if blood pressure is elevated to assess for preeclampsia.
The results of this study will help determine whether vitamin D supplementation is an effective and safe strategy for preventing recurrent preeclampsia in women at high risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Supplementation | Experimental | Drug: Vitamin D (Cholecalciferol )Participants randomized to this arm will receive oral vitamin D |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomized to this arm will receive a matching placebo with the same taste, color, and consistency as the active treatment |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women
- Singleton pregnancy (on USG)
- Gestational age ≥ 24-weeks (on LMP method) and
- Past medical history of pre-eclampsia (on medical record)
Key exclusion criteria (5 listed)
- Pre-existing chronic hypertension
- Cardiac diseases (congenital or acquired)
- Renal disease
- Thyrotoxicosis (on history and medical record) and
- 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 D (Cholecalciferol )Vitamin D 4000 IU will be administered orally once daily from enrollment until 36 weeks of gestation. They will attend follow-up visits every 2 weeks for blood pressure monitoring and clinical assessment, with serum vitamin D levels measured every 4 weeks. | Drug | Vitamin D Supplementation |
| PlaceboA matching placebo with the same taste, color, and consistency as vitamin D will be administered orally once daily from enrollment until 36 weeks of gestation for comparison with vitamin D supplementation. | Drug | Placebo |
Primary outcome
Recurrence of Preeclampsia
Time frame: From randomization until 36 weeks of gestation
Recurrence of preeclampsia will be defined as the development of new-onset hypertension (blood pressure ≥140/90 mmHg) and proteinuria (≥1+ on urine dipstick) at 20 weeks of gestation or later in women with a previous history of preeclampsia. Participants with elevated blood pressure will undergo urine protein testing to confirm the diagnosis.
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 21 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
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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
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
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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. This study is not recruiting at the moment.
Nidda Y Assistant Professor, FCPS study chair
CMH Multan Institute of Medical Sciences
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 (Cholecalciferol ) in people with Preeclampsia, run by CMH Multan Institute of Medical Sciences 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 4 inclusion and 5 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 21 Jul 2026. 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?
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?
Recurrence of Preeclampsia (time frame: From randomization until 36 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 21 Jul 2026.