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Could High-Dose vitamin D3 shield pregnant women from preeclampsia?

NCT ID NCT07648706

Prevention Sponsor: Sana'a University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two different doses of vitamin D3 supplements in pregnant women who have low vitamin D levels. The goal is to see if a higher dose (50,000 IU every two weeks) is better than a lower dose (5,000 IU weekly) at preventing preeclampsia, a serious pregnancy complication involving high blood pressure. The trial enrolls women with a single baby, between 8 and 18 weeks of pregnancy, and follows them through delivery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vitamin D3
What this could lead to
If successful, this could show that higher vitamin D3 doses during pregnancy reduce the risk of preeclampsia, a dangerous condition for both mother and baby.
What could go wrong
This is a relatively small, single-hospital study, so results may not apply to all populations. The optimal dose and safety of high-dose vitamin D3 in pregnancy are still being explored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 268 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Singleton pregnancy * Pregnant women between 8 and 18 weeks of gestation * Serum 25-hydroxyvitamin D \[25(OH)D\] level \< 25 ng/mL * Willing and able to provide written informed consent * Planning to receive ongoing antenatal care and deliver at Al-Thawra Modern General Hospital. Exclusion Criteria: * Uncontrolled chronic hypertension * Current use of vitamin D supplementation before enrollment * Severe chronic kidney disease * Pre-existing diabetes mellitus * Autoimmune or immunological disorders * Known fetal congenital anomalies * Primary hyperparathyroidism * Thyroid disease * Use of medications that affect vitamin D or calcium metabolism * Inability or unwillingness to comply with the study protocol or follow-up schedule

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Conditions

The condition(s) this trial relates to.

vitamin D deficiency preeclampsia prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Preeclampsia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Faculty of Medicine and Health Sciences, Sana'a University

    RECRUITING

    Sanaa, Maeen District, Yemen

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