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

NCT02395081 | Completed Results DMC

• 1 other identifier: 14-0591-02
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Vitamin D Deficiency

Keywords

pregnancy; Mongolia; Vitamin D; preeclampsia

Outcome Measures

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)

  36 weeks gestation or delivery, if delivery occurred before 36 weeks

Secondary Outcomes (13)

• The Number of Participants With Preeclampsia

  After 20 weeks gestation

• Average Monthly Blood Pressure

  During pregnancy

• Arterial Tonometry

  36 weeks gestation

• Number of Patients With Preterm Delivery as Measured by Clinical Diagnosis

  During pregnancy

• Casarean Section as Measured by Medical Record Abstraction

  Delivery

Study Arms (3)

600 IU

PLACEBO COMPARATOR

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

Dietary Supplement: 600 IU Vitamin D3 in prenatal vitamin

2000 IU

EXPERIMENTAL

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

Dietary Supplement: 2000 IU Vitamin D3 in prenatal vitamin

4000 IU

EXPERIMENTAL

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

Dietary Supplement: 4000 IU Vitamin D3 in prenatal vitamin

Interventions

600 IU Vitamin D3 in prenatal vitamin DIETARY_SUPPLEMENT

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

600 IU

2000 IU Vitamin D3 in prenatal vitamin DIETARY_SUPPLEMENT

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

2000 IU

4000 IU Vitamin D3 in prenatal vitamin DIETARY_SUPPLEMENT

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

4000 IU

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Center for Maternal and Child Health Research, Mongolia: collaborator
• Zuun Kharaa Hospital: collaborator

Study Sites (1)

Zuun Kharaa Hospital

Selenge, Selenge Province, Mongolia

Location

Related Publications (1)

• 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.

  PMID: 30552064 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Pre-Eclampsia

Interventions

Cholecalciferol; Prenatal Care

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Janet Rich-Edwards
• Organization: Brigham and Women's Hospital

jr33@partners.org

617-525-8264

Study Officials

• Janet Rich-Edwards, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Developmental Epidemiology

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: March 20, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 23, 2021
• Results First Posted: March 23, 2021

Record last verified: 2021-02

Locations

MO (1)