PreeclampsiaPhase 4MAMANCT07510568
Vitamin D Supplementation Among Pregnant Women in Uganda for the Prevention of Hypertensive Disorders in Pregnancy, and Other Adverse Maternal and Foetal Outcomes
A Phase 4 study testing oral 2.000 IU vitamin D3 (cholecalciferol) daily, in addition to routine ANC supplementations in people with Preeclampsia and Eclampsia, run by St Mary's Hospital, Lacor.
Trial summary
The goal of this randomised controlled trial is to investigate if vitamin D supplementation among pregnant women in Uganda prevents adverse maternal and foetal outcomes, with special emphasis on preeclampsia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia, Eclampsia, HELLP Syndrome
- What is being tested?
- oral 2.000 IU vitamin D3 (cholecalciferol) daily, in addition to routine ANC supplementations
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,980 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2027
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women of age ≥ 18 years, who attend ANC services at St. Mary's Hospital Lacor, satisfying the following criteria:
- with a viable intrauterine pregnancy,
- at gestational age at recruitment between 13 weeks 0 days and 27 weeks 6 days, and
- who consented to participate in the study.
Who cannot join
- women already on Vitamin D treatment prescribed by a physician.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Vitamin D Supplementation Among Pregnant Women in Uganda and for the Prevention of Adverse Obstetric Outcomes: a Randomized Controlled Trial
The goal of this randomised controlled trial is to investigate if vitamin D supplementation among pregnant women in Uganda prevents adverse maternal and foetal outcomes, with special emphasis on preeclampsia.
The main question it aims to answer is if Vitamin D supplementation, administered as oral vitamin D₃ at a dose of 2,000 IU once daily, from the time of recruitment to the time of delivery, reduces the incidence of preeclampsia, eclampsia and HELLP syndrome in pregnant women attending ANC at St. Mary's Hospital, Lacor, such incidence being monitored up to six (6) weeks after delivery.
Researchers will compare the effect of oral 2.000 IU vitamin D daily (intervention group) vs. oral placebo daily (control group) on the prevalence of adverse maternal and foetal outcomes.
Read the detailed description
Introduction:
Vitamin D deficiency is a global health issue, with an estimated prevalence in Africa of about 34%. Black pregnant and breastfeeding women are among the populations with the highest risk of deficiency, with a prevalence of up to 40% in urban Uganda.
Low Vitamin D status in pregnancy seems to be associated with multiple adverse obstetric outcomes, in particular with hypertensive disorders in pregnancy, gestational diabetes, severe postpartum haemorrhage, preterm birth, and low birth weight; these associations have been studied predominantly in Caucasian populations. Recent studies investigated Vitamin D supplementation in preventing preeclampsia, which is known to be more prevalent and severe in dark-skinned women, but results from Africa are scanty; little data have been published on the supplementation of vitamin D in pregnant women in sub-Saharan countries, including Uganda.
Objective: The objective of this trial is to investigate if vitamin D supplementation among pregnant women in Uganda prevents adverse maternal and foetal outcomes, with special emphasis on preeclampsia.
Methods: This will be a double-blinded randomized trial with parallel groups, where pregnant women attending ANC at St. Mary's Hospital, Lacor (Gulu, Northern Uganda), enrolled at gestational age between 13 and 27 weeks, confirmed by ultrasonography at the first antenatal visit, will be invited to participate. Enrolment is planned to start in the last quarter of 2025 and will last approximately 18 months.
Participants will be randomized in a two-armed randomization, with a 1:1 allocation ratio, into:
- Intervention group - 990 women will receive oral 2.000 IU vitamin D daily; or.
- Control group - 990 women will receive an oral placebo daily. A total of 1980 pregnant women will be included; participants will be screened for eligibility at admission and will be required to sign a consent. Questionnaires will be collected upon enrolment, with maternal socio-demographic characteristics and obstetric-medical factors. Study participants will be followed-up throughout the pregnancy, with ANC contacts scheduled at approximately 20, 26, 30, 34, 36, 38, and 40 weeks of gestation, each contact will comprise maternal physical examination, foetal well-being monitoring, the administration of sulfadoxine-pyrimethamine for malaria intermittent preventive treatment in pregnancy, the supplementation of iron and folic acid, and counselling about birth preparedness, nutrition, and danger signs during pregnancy. Upon delivery, information on maternal and foetal outcomes will be extracted from medical records. Participants will be followed up from delivery to 6 weeks postpartum.
The primary analysis will evaluate the effect of assignment to vitamin D supplementation compared with placebo on the incidence of preeclampsia, eclampsia, or HELLP syndrome, following an intention-to-treat principle. Secondary outcomes will include other adverse maternal outcomes, such as GH, GDM, APH, PPH, PROM and preterm birth, and adverse foetal outcomes, such as growth restriction and low APGAR scores.
Expected results: This study will investigate if the supplementation of Vitamin D in pregnant women in Uganda is effective in preventing preeclampsia, and other adverse foetal and maternal outcomes. The obtained results will pave the way for the recommendation of Vitamin D supplementation during ANC in Uganda, with potentially broad health benefits.
- Conditions
- Preeclampsia, Eclampsia, HELLP Syndrome
- Being tested
- oral 2.000 IU vitamin D3 (cholecalciferol) daily, in addition to routine ANC supplementations, Placebo
- Medical subject headings
- Pre-Eclampsia, Eclampsia, HELLP Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral 2.000 IU vitamin D3 (cholecalciferol) daily, in addition to routine ANC supplementationsDrug
The intervention group will comprise pregnant women attending ANC at St. Mary's Hospital, Lacor included in the study, who will be randomized to receive daily oral 2,000 IU Vitamin D3, from the recruitment to the delivery.
Eligible participants will be women of age ≥ 18 years, who consented to participate in the study, with a viable intrauterine pregnancy, and at gestational age at recruitment between 13 weeks 0 days and 27 weeks 6 days.
PlaceboOther
The placebo will be identical to the intervention, with the exception of Vitamin D3, and will have no known pharmacological or physiological activity
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Participants will receive oral 2.000 IU vitamin D daily Receives: Drug: oral 2.000 IU vitamin D3 (cholecalciferol) daily, in addition to routine ANC supplementations |
| Control group | Placebo comparator | Participants will receive an oral placebo daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the occurrence of maternal preeclampsia, eclampsia and HELLP syndrome.
For each participant, the first occurrence of preeclampsia, eclampsia, or HELLP syndrome during pregnancy will be considered for the primary analysis. The criteria for preeclampsia, eclampsia, or HELLP syndrome are reported in the Operational Definitions of the Study Protocol
Measured: From enrolment to 6 weeks postpartum
Secondary outcomes (12)
The occurrence of maternal Gestational Hypertension (GH)
The criteria for GH are defined in the Operational Definitions of the Study Protocol
Measured: From enrolment to 6 weeks postpartum
Fatal outcome of delivery (live birth or stillbirth), with APGAR score at 1 and 5 minutes
APGAR score is a widely known and standardized tool to asses the clinical conditions of a new-born immediately after birth, and will be measured at 1 minute and 5 minutes after birth.
Measured: At delivery, at 1 minute and 10 minutes after birth
Preterm birth, i.e., Gestational Age at delivery < 37 weeks
Weeks; the determination of the Gestational Age id defined in the Study Protocol
Measured: At delivery
Mode of delivery
By vaginal delivery or by Caesarean Section
Measured: At delivery
Admission to HDU or ICU
Measured: From enrolment to 6 weeks postpartum
New-born birth weight
In Kg
Measured: At delivery
Foetal sex and malformations
Measured: At delivery
New-born admission to Nursery or Neonatal Intensive Care Unit (NICU)
Measured: From delivery to 6 weeks postpartum
The occurrence of maternal Gestational Diabetes (GDM)
The criteria for GDM are defined in the Operational Definitions in the Study Protocol
Measured: From enrolment to delivery
The occurrence of maternal Antepartum Haemorrhage (APH)
The criteria for APH are defined in the Operational Definitions of the Study Protocol
Measured: From 28 weeks of Gestational Age to delivery
The occurrence of Primary Postpartum Haemorrhage (1.PPH)
The criteria for 1.PPH are defined in the Operational Definitions of the Study Protocol
Measured: From delivery to 24 hours post delivery
The occurrence of Prelabour Rupture of Membranes (PROM)
The criteria for PROM are defined in the Operational Definitions of the Study Protocol
Measured: From enrolment to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Mary's Hospital, Lacor
- Sponsor type
- University, hospital or other
- Collaborators
- University of Naples
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510568
- Sponsor's protocol ID
- MAMA trial
- Acronym
- MAMA
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation Among Pregnant Women in Uganda and for the Prevention of Adverse Obstetric Outcomes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07510568
- Acronym / sponsor ID
- MAMA / MAMA trial
- Conditions
- Preeclampsia, Eclampsia, HELLP Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,980 participants (estimated)
- Lead sponsor
- St Mary's Hospital, LacorUniversity, hospital or other
- Collaborators
- University of Naples
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Apr 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 randomised controlled trial is to investigate if vitamin D supplementation among pregnant women in Uganda prevents adverse maternal and foetal outcomes, with special emphasis on preeclampsia.
The main question it aims to answer is if Vitamin D supplementation, administered as oral vitamin D₃ at a dose of 2,000 IU once daily, from the time of recruitment to the time of delivery, reduces the incidence of preeclampsia, eclampsia and HELLP syndrome in pregnant women attending ANC at St. Mary's Hospital, Lacor, such incidence being monitored up to six (6) weeks after delivery.
Researchers will compare the effect of oral 2.000 IU vitamin D daily (intervention group) vs. oral placebo daily (control group) on the prevalence of adverse maternal and foetal outcomes.
Detailed description
Introduction:
Vitamin D deficiency is a global health issue, with an estimated prevalence in Africa of about 34%. Black pregnant and breastfeeding women are among the populations with the highest risk of deficiency, with a prevalence of up to 40% in urban Uganda.
Low Vitamin D status in pregnancy seems to be associated with multiple adverse obstetric outcomes, in particular with hypertensive disorders in pregnancy, gestational diabetes, severe postpartum haemorrhage, preterm birth, and low birth weight; these associations have been studied predominantly in Caucasian populations. Recent studies investigated Vitamin D supplementation in preventing preeclampsia, which is known to be more prevalent and severe in dark-skinned women, but results from Africa are scanty; little data have been published on the supplementation of vitamin D in pregnant women in sub-Saharan countries, including Uganda.
Objective: The objective of this trial is to investigate if vitamin D supplementation among pregnant women in Uganda prevents adverse maternal and foetal outcomes, with special emphasis on preeclampsia.
Methods: This will be a double-blinded randomized trial with parallel groups, where pregnant women attending ANC at St. Mary's Hospital, Lacor (Gulu, Northern Uganda), enrolled at gestational age between 13 and 27 weeks, confirmed by ultrasonography at the first antenatal visit, will be invited to participate. Enrolment is planned to start in the last quarter of 2025 and will last approximately 18 months.
Participants will be randomized in a two-armed randomization, with a 1:1 allocation ratio, into:
- Intervention group - 990 women will receive oral 2.000 IU vitamin D daily; or.
- Control group - 990 women will receive an oral placebo daily. A total of 1980 pregnant women will be included; participants will be screened for eligibility at admission and will be required to sign a consent. Questionnaires will be collected upon enrolment, with maternal socio-demographic characteristics and obstetric-medical factors. Study participants will be followed-up throughout the pregnancy, with ANC contacts scheduled at approximately 20, 26, 30, 34, 36, 38, and 40 weeks of gestation, each contact will comprise maternal physical examination, foetal well-being monitoring, the administration of sulfadoxine-pyrimethamine for malaria intermittent preventive treatment in pregnancy, the supplementation of iron and folic acid, and counselling about birth preparedness, nutrition, and danger signs during pregnancy. Upon delivery, information on maternal and foetal outcomes will be extracted from medical records. Participants will be followed up from delivery to 6 weeks postpartum.
The primary analysis will evaluate the effect of assignment to vitamin D supplementation compared with placebo on the incidence of preeclampsia, eclampsia, or HELLP syndrome, following an intention-to-treat principle. Secondary outcomes will include other adverse maternal outcomes, such as GH, GDM, APH, PPH, PROM and preterm birth, and adverse foetal outcomes, such as growth restriction and low APGAR scores.
Expected results: This study will investigate if the supplementation of Vitamin D in pregnant women in Uganda is effective in preventing preeclampsia, and other adverse foetal and maternal outcomes. The obtained results will pave the way for the recommendation of Vitamin D supplementation during ANC in Uganda, with potentially broad health benefits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Drug: oral 2.000 IU vitamin D3 (cholecalciferol) daily, in addition to routine ANC supplementationsParticipants will receive oral 2.000 IU vitamin D daily |
| Control group | Placebo comparator | Other: PlaceboParticipants will receive an oral placebo daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women of age ≥ 18 years, who attend ANC services at St. Mary's Hospital Lacor, satisfying the following criteria:
- with a viable intrauterine pregnancy,
- at gestational age at recruitment between 13 weeks 0 days and 27 weeks 6 days, and
- who consented to participate in the study.
Key exclusion criteria (1 listed)
- women already on Vitamin D treatment prescribed by a physician.
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 |
|---|---|---|
| oral 2.000 IU vitamin D3 (cholecalciferol) daily, in addition to routine ANC supplementationsThe intervention group will comprise pregnant women attending ANC at St. Mary's Hospital, Lacor included in the study, who will be randomized to receive daily oral 2,000 IU Vitamin D3, from the recruitment to the delivery. Eligible participants will be women of age ≥ 18 years, who consented to participate in the study, with a viable intrauterine pregnancy, and at gestational age at recruitment between 13 weeks 0 days and 27 weeks 6 days. | Drug | Intervention group |
| PlaceboThe placebo will be identical to the intervention, with the exception of Vitamin D3, and will have no known pharmacological or physiological activity | Other | Control group |
Primary outcome
The primary outcome will be the occurrence of maternal preeclampsia, eclampsia and HELLP syndrome.
Time frame: From enrolment to 6 weeks postpartum
For each participant, the first occurrence of preeclampsia, eclampsia, or HELLP syndrome during pregnancy will be considered for the primary analysis. The criteria for preeclampsia, eclampsia, or HELLP syndrome are reported in the Operational Definitions of the Study Protocol
12 secondary outcomes
The occurrence of maternal Gestational Hypertension (GH)
Time frame: From enrolment to 6 weeks postpartum
Fatal outcome of delivery (live birth or stillbirth), with APGAR score at 1 and 5 minutes
Time frame: At delivery, at 1 minute and 10 minutes after birth
Preterm birth, i.e., Gestational Age at delivery < 37 weeks
Time frame: At delivery
Mode of delivery
Time frame: At delivery
Admission to HDU or ICU
Time frame: From enrolment to 6 weeks postpartum
New-born birth weight
Time frame: At delivery
Foetal sex and malformations
Time frame: At delivery
New-born admission to Nursery or Neonatal Intensive Care Unit (NICU)
Time frame: From delivery to 6 weeks postpartum
The occurrence of maternal Gestational Diabetes (GDM)
Time frame: From enrolment to delivery
The occurrence of maternal Antepartum Haemorrhage (APH)
Time frame: From 28 weeks of Gestational Age to delivery
The occurrence of Primary Postpartum Haemorrhage (1.PPH)
Time frame: From delivery to 24 hours post delivery
The occurrence of Prelabour Rupture of Membranes (PROM)
Time frame: From enrolment to delivery
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 3 Apr 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral 2.000 IU vitamin D3 (cholecalciferol) daily, in addition to routine ANC supplementations in people with Preeclampsia and Eclampsia, run by St Mary's Hospital, Lacor.
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 1 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: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Cristina Reverzani, MBChB, MMED OBGY (+256 760776171, creverzani@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be the occurrence of maternal preeclampsia, eclampsia and HELLP syndrome. (time frame: From enrolment to 6 weeks postpartum). 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 3 Apr 2026.