Phase 2
Completed N=179
Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia
Source: ClinicalTrials.gov NCT03101150 ↗Enrolled (actual)
179
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Number of Participants With Pre-eclampsia in Both Arms — 6; 1 Participants — p=<0.05
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.
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 |
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. Informational only — not medical advice.