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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02395081
• Date of registration: 11/02/2015
• Prospective Registration: No
• Primary sponsor: Brigham and Women's Hospital
• Public title: Trial of Vitamin D Supplements to Raise Calcidiol Levels of Pregnant Women in Mongolia
• Scientific title: Trial of Vitamin D Supplements to Raise Calcidiol Levels of Pregnant Women in Mongolia
• Date of first enrolment: February 2015
• Target sample size: 360
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02395081
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Mongolia

Contacts

• Name: Janet Rich-Edwards, ScD
• Affiliation: Brigham and Women's Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Vitamin D Deficiency

Pregnancy

Intervention(s)

Dietary Supplement: 2000 IU Vitamin D3 in prenatal vitamin

Dietary Supplement: 4000 IU Vitamin D3 in prenatal vitamin

Dietary Supplement: 600 IU Vitamin D3 in prenatal vitamin

Primary Outcome(s)

Circulating 25(OH)D serum levels as measured by DiaSorin assay [Time Frame: 36 weeks gestation or delivery]

Secondary Outcome(s)

Bacterial vaginosis as measured by KOH wet mount [Time Frame: During pregnancy]

Proteinuria as measured by urine dipstick [Time Frame: 36-40 weeks gestation/delivery]

Caesarean section as measured by medical record abstraction [Time Frame: Delivery]

Large for gestational age neonate as measured by medical record abstraction [Time Frame: Delivery]

Arterial tonometry as measured by AtCor Medical SphygmoCor device [Time Frame: 36 weeks gestation]

Hypertensive disorders of pregnancy prevalence as measured by clinical diagnosis [Time Frame: During pregnancy]

Average monthly change in blood pressure as measured by automated Omron blood pressure cuff [Time Frame: During pregnancy]

Assisted vaginal delivery as measured by medical record abstraction [Time Frame: Delivery]

Preeclampsia prevalence as measured by new onset hypertension after 20 weeks gestation and proteinuria [Time Frame: During pregnancy]

Preterm delivery as measured by clinical diagnosis [Time Frame: During pregnancy]

Small for gestational age neonate as measured by medical record abstraction [Time Frame: Delivery]

Calcemia as measured by serum calcium test [Time Frame: 2 months after randomization and 36-40 weeks of pregnancy/delivery]

Secondary ID(s)

14-0591-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Center for Maternal and Child Health Research, Mongolia

Zuun Kharaa Hospital