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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
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Researchers at the USDA Western Human Nutrition Research Center and clinicians at UC Davis Medical Center are currently conducting a study on the effects of vitamin D supplementation during pregnancy on maternal health and immune function. The investigators believe that vitamin D supplementation at levels greater than the current recommendation is beneficial for maternal health during pregnancy. In particular, there is evidence that vitamin D deficiency during pregnancy puts women at greater risk for diseases like pre-eclampsia, which may be due to an imbalance in immune function at the placenta. This randomized, double-blind study is designed to test this hypothesis. Pregnant women who participate in the study receive either 400 IU or 2,000 IU of vitamin D per day for the duration of their pregnancy. The investigators will collect blood at three time points during pregnancy (16-20 weeks, 26-28 weeks, 36 weeks gestation) for analysis of immune function and vitamin D status. The investigators are also collecting data on clinical parameters, such as blood pressure and glucose tolerance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 400 IU Vitamin D3 | Placebo Comparator | Women in this study arm receive 400 IU of vitamin D3 per day, or what is in a standard prenatal multivitamin. They also receive a placebo study supplement. |
|
| 2,000 IU Vitamin D3 | Experimental | Women in this arm receive 2,000 IU vitamin D per day: 400 IU from a standard prenatal multivitamin plus an additional 1,600 IU vitamin D3 in the study supplement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 400 IU vitamin D3 | Dietary Supplement | Women in this study arm receive 400 IU of vitamin D3 per day, or what is in a standard prenatal multivitamin. They also receive a placebo study supplement. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in T-cell cytokine expression | Inflammatory and regulatory cytokines will be measured in cultured T-cells by flow cytometry. | 16-20 wks, 26-28 wks, and 36 wks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vitamin D status | Serum 25-OH vitamin D and 1, 25 (OH)2 Vitamin D | 16-20 wks, 26-28 wks, 36 wks gestation |
| Change in innate immune function | Monocyte and NK cell cytokine expression and response to stimulation with Toll-like Receptor agonists. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles B Stephensen, PhD | USDA, ARS, Western Human Nutrition Research Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USDA-Western Human Nutrition Research Center | Davis | California | 95616 | United States | ||
| UC Davis Medical Center Obstetrics & Gynecology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39077939 | Derived | Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5. | |
| 27655755 | Derived | Zerofsky MS, Jacoby BN, Pedersen TL, Stephensen CB. Daily Cholecalciferol Supplementation during Pregnancy Alters Markers of Regulatory Immunity, Inflammation, and Clinical Outcomes in a Randomized Controlled Trial. J Nutr. 2016 Nov;146(11):2388-2397. doi: 10.3945/jn.116.231480. Epub 2016 Sep 21. |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 2,000 IU Vitamin D3 | Dietary Supplement | Women in this arm receive 2,000 IU vitamin D per day: 400 IU from a standard prenatal multivitamin plus an additional 1,600 IU vitamin D3 in the study supplement. |
|
| 16-20 wks, 26-28 wks, 36 wks gestation |
| Change in blood pressure | Blood pressure will be measured using standard techniques. | 16-20 wks, 26-28 wks, 36 wks gestation |
| Sacramento |
| California |
| 95817 |
| United States |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |