N/A
Completed N=360
Trial of Vitamin D Supplements to Raise Calcidiol Levels of Pregnant Women in Mongolia
Source: ClinicalTrials.gov NCT02395081 ↗Enrolled (actual)
360
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Total Serum 25(OH)D Concentration — 46; 70; 81 nmol/l
Summary
A double-blind randomized, placebo-controlled trial comparing the impact of 600 IU, 2000 IU, or 4000 IU of Vitamin D3 on third trimester 25(OH)D levels and change from baseline. The Vitamin D will be integrated in a standard prenatal vitamin, which will be taken from 12-16 weeks' gestation and continue throughout pregnancy. Umbilical cord 25(OH)D levels will also be determined. The investigators will generate preliminary data regarding Vitamin D intake and hypertensive disorders, blood pressure, and arterial function measured by tonography. The investigators will independently test blood pressure and proteinuria to identify preeclampsia cases.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Serum 25(OH)D Concentration |
46; 70; 81 | — |
| SECONDARY The Number of Participants With Preeclampsia |
1; 0; 0 | — |
| SECONDARY Average Monthly Blood Pressure |
104.5; 104.5; 105.5; 105.1; 103.6; 105.4 | 0.70 |
| SECONDARY Arterial Tonometry |
— | — |
| SECONDARY Number of Patients With Preterm Delivery as Measured by Clinical Diagnosis |
9; 8; 5 | 0.49 |
| SECONDARY Casarean Section as Measured by Medical Record Abstraction |
22; 27; 26 | 0.79 |
| SECONDARY Assisted Vaginal Delivery as Measured by Medical Record Abstraction |
0; 0; 0 | — |
| SECONDARY Number of Small for Gestational Age (SGA) Neonates as Measured by Medical Record Abstraction |
1; 2; 2 | 0.83 |
| SECONDARY Number of Large for Gestational Age (LGA) Neonates as Measured by Medical Record Abstraction |
25; 26; 33 | 0.39 |
| SECONDARY Mean Calcemia as Measured by Serum Calcium Test (2mo) |
2.2; 2.2; 2.2 | 0.24 |
| SECONDARY Number of Patients With Proteinuria as Measured by Urine Dipstick |
2; 2; 0 | 0.39 |
| SECONDARY Number of Patients With Hypertensive Disorders of Pregnancy as Measured by Clinical Diagnosis |
4; 3; 3 | 0.89 |
| SECONDARY Number of Patients With Bacterial Vaginosis as Measured by Potassium Hydroxide (KOH) Wet Mount |
17; 19; 18 | 0.95 |
| SECONDARY Mean Calcemia as Measured by Serum Calcium Test (36-40 Weeks) |
2.3; 2.3; 2.3 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 or older
- 12-16 weeks pregnant
- Receiving prenatal care at Zuun Kharaa Hospital and planning to deliver at Zuun Kharaa Hospital
- Willing not to take any additional vitamin D supplements, other than the study dispensed pills
Exclusion Criteria
- Existing known seizure disorder, renal failure, parathyroid disease, thyroid disease, sarcoidosis, cancer, or tuberculosis. (Tuberculosis is routinely screened in pregnancy)
- History of kidney stones
- Known sensitivity to multivitamin preparations
- Taking vitamin D supplements containing >600 IU/day.
Data sourced from ClinicalTrials.gov (NCT02395081). 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.