Vitamin D3 Supplementation Regimens and Preeclampsia Risk
ConditionPreeclampsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorSana'a University
About this trial
This study is a randomized controlled trial with two parallel groups connected at Al-Thawra Modern General Hospital in Sana'a, Yemen.
It aims to compara the effect of two different vitamin D3 supplementation regimens during pregnancy on the risk of pre-eclampsia among women with confirmed vitamin D deficiency.
Pregnant women attending antenatal care and diagnosed with vitamin D deficiency will be screened for eligibility. Eligible participants will be randomly assigned to one of two intervention groups:one group receiving vitamin D3 50,000 IU every two weeks and the other group receiving vitamin D3 5,000 IU weekly,in addition to standard antenatal care.
The study will include singleton pregnancies between 8\_18 weeks of gestation with serum 25-hydroxyvitamin D level below 25 ng /mL . Women with chronic conditions that may affect pregnancy outcomes or vitamin D metabolism will be excluded. Participants will be followed throughout pregnancy to assess the development of pre-eclampsia and other maternal and fetal outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Uncontrolled chronic hypertension
Current use of vitamin D supplementation before enrollment
Severe chronic kidney disease
Pre-existing diabetes mellitus
Trial design
Design model
Parallel
Treatments tested in this trial
Vitamin D3
Dietary supplementArm 1: Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 50,000 IU every two weeks according to their randomized group assignment.
Vitamin D3
Dietary supplementOral vitamin D3 supplementation administered during pregnancy. Participants will receive : 5,000 IU every week according to their randomized group assignment.
Treatment groups
268 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Vitamin D3 50,000 IU every 2 weeksExperimental treatment 1 intervention
Group B: Arm 2 : Vitamin D3 5,000 IU every weekExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Pre-eclampsia events
Occurance of preeclampsia during pregnancy , diagnosed according standared clinical criteria including new onset hypertention after 20weeks of gestation with proteinuria or other feature of maternal organ dysfunction.
Time frame
From 20 weeks of gestation until deliverySecondary outcomes
1
Severity of Preeclampsia
Description Severity of preeclampsia assessed by the need for preterm delivery, maternal intensive care unit admission, or other severe maternal complications.
Time frame
At diagnosis of preeclampsia until delivery2
Gestational Age at Onset of Preeclampsia
Gestational age in weeks at the time of first diagnosis of preeclampsia.
Time frame
At first diagnosis of preeclampsia3
Occurrence of Severe Maternal Complications
Occurrence of HELLP syndrome, eclampsia, or placental abruption during pregnancy
Time frame
From enrollment until delivery4
Incidence of Gestational Diabetes Mellitus
Occurrence of gestational diabetes diagnosed according to standard clinical criteria.
Time frame
From enrollment until delivery]Sponsors and contacts
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Source ClinicalTrials.gov