Prevention of pre-eclampsia through vitamin D supplementation: a single-blinded randomized clinical trial without placebo

Pre-eclampsia in Kivu: vitamin D levels and impacts of vitamin D supplementation on obstetric-neonatal outcomes in primigravida

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN46539495

Enrollment

672

Registered

2020-11-17

Start date

2020-03-01

Completion date

Unknown

Last updated

2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-eclampsia Pregnancy and Childbirth Pre-eclampsia

Interventions

Patients will be divided into two groups based on gestational age (randomized into two groups). Supplemented group: 60,000 IU of VITOSSAMIN® D3 (cholecalciferol) orally in one dose per month from the

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Primipara, monoembryonic pregnancy (=15 weeks of amenorrhoea for pregnant women to be supplemented)

Exclusion criteria

Exclusion criteria: 1. IMC 7 mmol/l or blood sugar >11 mmol/l), hypercalcemia (>2.65 mmol/l) and other phosphocalcic pathologies, bone diseases, lithium intake, digestive malabsorption

Design outcomes

Primary

Measure	Time frame
Percentage of patients with preeclampsia during pregnancy, evidenced by the occurrence of hypertension (systolic blood pressure [SBP] greater than or equal to 140 mmHg and/or diastolic blood pressure [DBP] greater than or equal to 90 mmHg, taken twice 4-6 hours apart, at rest) and 2 x proteinuria after 20 weeks of amenorrhoea	—

Secondary

Measure	Time frame
For the patients: 1. Gestational age for any incident and for preeclampsia, measured during antenatal care or other consultations by taking blood pressure, albuminuria measurement to confirm preeclampsia from recruitment (enrollment) to postpartum 2. Other clinical signs: given the atypical forms of preeclampsia, some clinical signs according to ACOG may allow the diagnosis of preeclampsia in the absence of proteinuria. The occurrence of these signs is monitored from the time of enrolment until delivery by means of an anamnesis, clinical and laboratory examination, and the pregnant woman is monitoring the antenatal care, of which she is aware 3. Incidents (eclampsia, detachment of the normally inserted placenta, maternal death) measured according to clinical, paraclinical (ultrasound and biology) examination from enrolment to postpartum (or death) 4. Serum concentration of 25OH-D, measured using iChroma II analyser (Boditech Med Inc, South Korea), at enrollment when the pregnant woman is carrying a pregnancy of age =14 weeks of amenorrhoea for the gestates to be supplemented and between 34 weeks of amenorrhoea and delivery (thus two samples for each subject), and for the other group after 14 weeks of amenorrhoea and between 34 weeks of amenorrhea and delivery In newborns: 1. Birth weight measured using scale at birth 2. Height measured using scale at birth 3. Cranial perimeter measured by tape measure by taking the circumference of the head through the glabella just after delivery 4. Intrauterine growth retardation noted at birth but detected by ultrasound as the pregnant woman is following ANC. Confirmation is done at birth with the use of tables 5. Death in utero observed after inclusion in the cohort (as it can occur at any time) and diagnosed by ultrasound before birth	—

Measure

Time frame

For the patients: 1. Gestational age for any incident and for preeclampsia, measured during antenatal care or other consultations by taking blood pressure, albuminuria measurement to confirm preeclampsia from recruitment (enrollment) to postpartum 2. Other clinical signs: given the atypical forms of preeclampsia, some clinical signs according to ACOG may allow the diagnosis of preeclampsia in the absence of proteinuria. The occurrence of these signs is monitored from the time of enrolment until delivery by means of an anamnesis, clinical and laboratory examination, and the pregnant woman is monitoring the antenatal care, of which she is aware 3. Incidents (eclampsia, detachment of the normally inserted placenta, maternal death) measured according to clinical, paraclinical (ultrasound and biology) examination from enrolment to postpartum (or death) 4. Serum concentration of 25OH-D, measured using iChroma II analyser (Boditech Med Inc, South Korea), at enrollment when the pregnant woman is carrying a pregnancy of age =14 weeks of amenorrhoea for the gestates to be supplemented and between 34 weeks of amenorrhoea and delivery (thus two samples for each subject), and for the other group after 14 weeks of amenorrhoea and between 34 weeks of amenorrhea and delivery In newborns: 1. Birth weight measured using scale at birth 2. Height measured using scale at birth 3. Cranial perimeter measured by tape measure by taking the circumference of the head through the glabella just after delivery 4. Intrauterine growth retardation noted at birth but detected by ultrasound as the pregnant woman is following ANC. Confirmation is done at birth with the use of tables 5. Death in utero observed after inclusion in the cohort (as it can occur at any time) and diagnosed by ultrasound before birth

—

Countries

Congo, Democratic Republic

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026