Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-31 @ 2:57 AM
Study NCT ID:
NCT01417351
Status:
COMPLETED
Last Update Posted:
2013-07-23
First Post:
2011-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Vitamin D Supplementation During Pregnancy on Clinical Outcomes and Immune Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-22', 'studyFirstSubmitDate': '2011-08-12', 'studyFirstSubmitQcDate': '2011-08-15', 'lastUpdatePostDateStruct': {'date': '2013-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in T-cell cytokine expression', 'timeFrame': '16-20 wks, 26-28 wks, and 36 wks gestation', 'description': 'Inflammatory and regulatory cytokines will be measured in cultured T-cells by flow cytometry.'}], 'secondaryOutcomes': [{'measure': 'Change in Vitamin D status', 'timeFrame': '16-20 wks, 26-28 wks, 36 wks gestation', 'description': 'Serum 25-OH vitamin D and 1, 25 (OH)2 Vitamin D'}, {'measure': 'Change in innate immune function', 'timeFrame': '16-20 wks, 26-28 wks, 36 wks gestation', 'description': 'Monocyte and NK cell cytokine expression and response to stimulation with Toll-like Receptor agonists.'}, {'measure': 'Change in blood pressure', 'timeFrame': '16-20 wks, 26-28 wks, 36 wks gestation', 'description': 'Blood pressure will be measured using standard techniques.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pregnancy', 'immune function'], 'conditions': ['Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '39077939', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '27655755', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women\n* Less than 20 weeks gestation\n* Over 18 years of age\n* Able to swallow nutritional supplements\n\nExclusion Criteria:\n\n* Use of medications known to affect vitamin D metabolism\n* Diagnosis of type 1 diabetes\n* History of thyroid, renal, or liver disease\n* Problems with digestion or absorption'}, 'identificationModule': {'nctId': 'NCT01417351', 'briefTitle': 'Effects of Vitamin D Supplementation During Pregnancy on Clinical Outcomes and Immune Function', 'organization': {'class': 'FED', 'fullName': 'USDA, Western Human Nutrition Research Center'}, 'officialTitle': 'Assessment of Inflammatory Markers and Pregnancy Outcomes in Vitamin D-Supplemented Women at Risk of Vitamin D Deficiency: A Double-Blind, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '217516'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '400 IU Vitamin D3', 'description': '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.', 'interventionNames': ['Dietary Supplement: 400 IU vitamin D3']}, {'type': 'EXPERIMENTAL', 'label': '2,000 IU Vitamin D3', 'description': '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.', 'interventionNames': ['Dietary Supplement: 2,000 IU Vitamin D3']}], 'interventions': [{'name': '400 IU vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['400 IU Vitamin D3']}, {'name': '2,000 IU Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['2,000 IU Vitamin D3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'USDA-Western Human Nutrition Research Center', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center Obstetrics & Gynecology', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Charles B Stephensen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'USDA, ARS, Western Human Nutrition Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA, Western Human Nutrition Research Center', 'class': 'FED'}, 'collaborators': [{'name': 'University of California, Davis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}