Preventing Health Disparities During Pregnancy Through Vitamin D Supplementation
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| ClinicalTrials.gov Identifier: NCT01932788 |
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Recruitment Status :
Completed
First Posted : August 30, 2013
Last Update Posted : May 2, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vitamin D3 Deficiency | Drug: Vitamin D3 4000 IU in gummy form Drug: Placebo gummy vitamin | Phase 3 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 410 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Preventing Health Disparities During Pregnancy Through Vitamin D Supplementation |
| Actual Study Start Date : | January 2013 |
| Actual Primary Completion Date : | April 30, 2017 |
| Actual Study Completion Date : | April 30, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Vitamin D 4000 IU
Subjects 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.
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Drug: Vitamin D3 4000 IU in gummy form
Subjects 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. |
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Placebo Comparator: placebo gummy vitamin
Supplementation with placebo gummy vitamin form, plus the standard prenatal vitamin (containing 400 IU vitamin D3)
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Drug: Placebo gummy vitamin
Subjects 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. |
- Maternal and neonatal health status as a function of maternal and infant vitamin D status [ Time Frame: These visits will include the initial recruitment of mother at 10-14 weeks of pregnancy, monthly study visits, delivery study visit. Nine months total. ]Because the primary endpoint of the study is change in 25(OH)D from baseline to delivery, the primary analysis will be restricted to participants who have remained in the study until delivery and provided a blood sample within 6 weeks prior to delivery, at delivery, or at the post-delivery visit (completers-only analysis).
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| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932788
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Principal Investigator: | Carol L Wagner, MD | Medical University of South Carolina |
Publications:
| Responsible Party: | Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT01932788 History of Changes |
| Other Study ID Numbers: |
20570 |
| First Posted: | August 30, 2013 Key Record Dates |
| Last Update Posted: | May 2, 2018 |
| Last Verified: | May 2018 |
Keywords provided by Medical University of South Carolina:
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pregnancy Vitamin D status |
Additional relevant MeSH terms:
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Vitamins Vitamin D Ergocalciferols Cholecalciferol |
Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |