Phase 2
N=179
Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia
Vitamin D Deficiency · Pre-Eclampsia
Bottom Line
View on ClinicalTrials.gov: NCT03101150 ↗Enrolled (actual)
179
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Number of Participants With Pre-eclampsia in Both Arms — 6; 1 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 400 IU Vitamin D3 (Drug); 4000 IU Vitamin D3 (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- King Fahad Medical City
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Pre-eclampsia in Both Arms |
6; 1 | <0.05 sig |
| SECONDARY Change in Vitamin D Level |
35.3; 72.3 | <0.0001 sig |
| SECONDARY Number of Patients With Intrauterine Growth Retardation |
18; 8 | <0.02 sig |
Summary
Vitamin D deficient pregnant ladies were selected and randomized into 2 groups for routine daily dose of multivitamin (400IU vitamin D3) versus maximum safest treatment daily dose (4000IU vitamin D3). Participants were assessed and compared for number of pre-eclampsia cases.
Eligibility Criteria
Inclusion Criteria
- Confirmed singleton pregnancy of less than 13 completed weeks of gestation at the time of consent.
- Planned to receive antenatal care in King Fahad Medical City antenatal clinic.
- The ability to provide written informed consent at the first visit.
- Low risk pregnancy; and Serum vitamin D3 levels less than < 25nmol/L.
Exclusion Criteria
- Mothers with pregnancy with abnormal foetus.
- Previous history of hypertension, pre-eclampsia, recurrent miscarriages.
- Chronic kidney disease, chronic liver disease, and malignancy.
Data sourced from ClinicalTrials.gov (NCT03101150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.