Trial of Vitamin D Supplements to Raise Calcidiol Levels of Pregnant Women in Mongolia

Browse trials for

• Vitamin D Deficiency 801
• Pre-Eclampsia 916

Keywords

• pregnancy
• Mongolia
• Vitamin D
• preeclampsia

Vitamin D Deficiency

801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.

This study's enrollment of 360 is above the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.

Study arms

• Placebo comparator
  600 IU

  Women will receive prenatal vitamins containing 600 IU of Vitamin D.

  Dietary Supplement: 600 IU Vitamin D3 in prenatal vitamin

• Experimental
  2000 IU

  Women will receive prenatal vitamins containing 2000 IU of Vitamin D.

  Dietary Supplement: 2000 IU Vitamin D3 in prenatal vitamin

• Experimental
  4000 IU

  Women will receive prenatal vitamins containing 4000 IU of Vitamin D.

  Dietary Supplement: 4000 IU Vitamin D3 in prenatal vitamin

Interventions

• Dietary supplement600 IU Vitamin D3 in prenatal vitamin

  Women will receive 600 IU 25(OH)D in prenatal vitamin.

• Dietary supplement2000 IU Vitamin D3 in prenatal vitamin

  Women will receive 2000 IU 25(OH)D in prenatal vitamin.

• Dietary supplement4000 IU Vitamin D3 in prenatal vitamin

  Women will receive 4000 IU 25(OH)D in prenatal vitamin.

Primary outcomes

1. Total Serum 25(OH)D Concentration

   Circulating vitamin D at the end of the study as measured by VIDAS® enzyme linked fluorescent assay (ELFA)

   Time frame: 36 weeks gestation or delivery, if delivery occurred before 36 weeks

Secondary outcomes

1. The Number of Participants With Preeclampsia

   Preeclampsia as measured by new onset hypertension after 20 weeks gestation and proteinuria.

   Time frame: After 20 weeks gestation

2. Average Monthly Blood Pressure

   Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) were measured in mm Hg at each antenatal care visit by the Study Coordinator, using the Omron- Elite 7300 (Omron Healthcare, Bannockburn, Illinois, USA) automated blood pressure monitor. Three blood pressure readings were taken after at least five minutes seated rest. For the analysis of mean blood pressures at each antenatal visit, the three readings were averaged for each participant.

   Time frame: During pregnancy

3. Arterial Tonometry

   Investigators will assess Augmentation Index (AIx) and Pulse Wave Velocity (PWV) by study arm, as measured by AtCor Medical SphygmoCor device. THIS TONOMETER FAILED AND COULD NOT BE REPAIRED, SO WE ARE NOT PRESENTING THESE DATA AS OUTCOMES.

   Time frame: 36 weeks gestation

4. Number of Patients With Preterm Delivery as Measured by Clinical Diagnosis

   Gestational age was determined clinically by last menstrual period and by routine first trimester ultrasound which was universal; where these differed by more than 10 days, the ultrasound date was used. Gestational age at delivery was recorded by clinicians and rounded to the nearest week. Preterm delivery was defined as delivery before the 37th week of gestation.

   Time frame: During pregnancy

5. Casarean Section as Measured by Medical Record Abstraction

   Cesarean section was abstracted from the labor and delivery chart.

   Time frame: Delivery

6. Assisted Vaginal Delivery as Measured by Medical Record Abstraction

   Assisted vaginal delivery with forceps delivery was abstracted from the labor and delivery chart.

   Time frame: Delivery

7. Number of Small for Gestational Age (SGA) Neonates as Measured by Medical Record Abstraction

   SGA defined by the lowest 10th percentiles of sex-specific birthweight for gestational age charts of the INTERGROWTH-21st study

   Time frame: Delivery

8. Number of Large for Gestational Age (LGA) Neonates as Measured by Medical Record Abstraction

   LGA defined by the highest 10th percentiles of sex-specific birthweight for gestational age charts of the INTERGROWTH-21st study

   Time frame: Delivery

9. Mean Calcemia as Measured by Serum Calcium Test (2mo)

   Measured on a semi-automated photometer (Humalyzer 3500, Human Diagnostics, Magdeburg, Germany)

   Time frame: 2 months after randomization

10. Number of Patients With Proteinuria as Measured by Urine Dipstick

    Proteinuria at last antenatal visit (usually 36-40 weeks' gestation), measured by 1+ Standard Diagnostics UroColor 10 10 (Kyonggi-do, South Korea) reagent strips

    Time frame: 36-40 weeks gestation/delivery

11. Number of Patients With Hypertensive Disorders of Pregnancy as Measured by Clinical Diagnosis

    In Mongolia, clinician-diagnosed preeclampsia may include a blood pressure increases \>30 mm Hg above early pregnancy, with or without documented hypertension, proteinuria, or symptoms such as headache and edema

    Time frame: During pregnancy

12. Number of Patients With Bacterial Vaginosis as Measured by Potassium Hydroxide (KOH) Wet Mount

    Bacterial vaginosis was routinely screened by potassium hydroxide wet mount at the first antenatal visit, at 28 weeks' and 32 weeks' gestation. It was also diagnosed by whiff test. We included both wet mount and whiff test positive in the bacterial vaginosis endpoint

    Time frame: During pregnancy

13. Mean Calcemia as Measured by Serum Calcium Test (36-40 Weeks)

    Measured on a semi-automated photometer (Humalyzer 3500, Human Diagnostics, Magdeburg, Germany)

    Time frame: 36-40 weeks of pregnancy/delivery

Baseline characteristics

Publications

• Enkhmaa D, Tanz L, Ganmaa D, Enkhtur S, Oyun-Erdene B, Stuart J, Chen G, Carr A, Seely EW, Fitzmaurice G, Buyandelger Y, Sarantsetseg B, Gantsetseg G, Rich-Edwards J. Randomized trial of three doses of vitamin D to reduce deficiency in pregnant Mongolian women. EBioMedicine. 2019 Jan;39:510-519. doi: 10.1016/j.ebiom.2018.11.060. Epub 2018 Dec 11. PubMed 30552064 ↗