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Vitamin D3 Deficiency | Preventing Health Disparities During Pregnancy Through Vitamin D Supplementation

Vitamin D3 Deficiency research study

What is the primary objective of this study?

The purpose of this study is to give all mothers the best chance for a healthy pregnancy through vitamin D supplementation. We will study women of diverse racial/ethnic backgrounds who will receive either the current vitamin D standard of 400 IU/day (in the prenatal vitamin) or 4000 IU/day (dose found in previous pregnancy studies to achieve vitamin D sufficiency). This research is sponsored by the W.K. Kellogg Foundation and the Medical University of South Carolina. The purpose of this study is to examine the effectiveness and infection-fighting properties of the body in relationship to vitamin D levels. This study is being done at the Medical University of South Carolina (MUSC) clinics, and will involve approximately 450 volunteers.

Who is eligible to participate?

Inclusion Criteria: - Any mother (18-45 years of age) who presents to her obstetrician or midwife at the Medical University of SC (MUSC), Charleston, SC obstetrical facilities within the first 14 weeks after her last menstrual period (LMP) with confirmation of a singleton pregnancy will be eligible for enrollment in the study. Mothers of diverse ethnic backgrounds (African-American, Asian, Caucasian and Hispanic) will be actively recruited. Exclusion Criteria: - Mothers with pre-existing calcium, uncontrolled thyroid disease, parathyroid conditions, or who require chronic diuretic or cardiac medication therapy including calcium channel blockers will not be eligible for enrollment into the study. Mothers with pre-existing sickle cell disease (not trait only), sarcoidosis, Crohn's disease, or ulcerative colitis may not participate in the study. In addition, because of the potentially confounding effect of multiple fetuses, mothers with multiple gestations will not be eligible for participation in the study. A sub-group of approximately 100 subjects with known diabetes, hypertension, HIV, or morbid obesity (body mass index > 49) will participate in the study.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Vitamin D3 Deficiency

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Vitamin D3 4000 IU in gummy formSubjects randomized to the Vitamin D3 4000 IU gummy vitamin arm, the investigational drug, will consume 4 gummies/day beginning at 10-14 weeks of your pregnancy. All subjects will consume a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of your pregnancy.

Drug:Placebo gummy vitaminSubjects randomized to receive placebo, also in gummy form but manufactured without Vitamin D3, will consume 4 gummies/day beginning at 10-14 weeks of pregnancy. All subjects will take a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of pregnancy.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Vitamin D 4000 IUSubjects randomized into this arm will receive supplementation with 4000 IU/day vitamin D3 in gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3.

placebo gummy vitaminSupplementation with placebo gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3)

Study Status

Completed

Start Date: January 2013

Completed Date: April 30, 2018

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Number of Participants With Greater Than 100 Nmol/L 25(OH)D (Converted Vitamin D)

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Carol L Wagner, MD

Lead Sponsor: Medical University of South Carolina

Collaborator: W.K. Kellogg Foundation

More information:https://clinicaltrials.gov/show/NCT01932788

Hamilton SA, McNeil R, Hollis BW, Davis DJ, Winkler J, Cook C, Warner G, Bivens B, McShane P, Wagner CL. Profound Vitamin D Deficiency in a Diverse Group of Women during Pregnancy Living in a Sun-Rich Environment at Latitude 32°N. Int J Endocrinol. 2010;2010:917428. doi: 10.1155/2010/917428. Epub 2010 Dec 9.

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