Low vitamin D levels and outcomes after total knee and hip arthroplasty Save

Date Added
September 15th, 2016
PRO Number
Pro00053191
Researcher
Jacob Drew
Keywords
Aging, Arthritis, Bone, Joint, Nutrition, Surgery, Vitamin D
Summary

Low vitamin d levels are common among patients undergoing orthopedic surgery. However, very little is known about how vitamin d affects outcomes in patients undergoing total joint replacement surgery. Our study will look at how common low vitamin d status is among patients undergoing total hip and total knee replacement surgery. We will also look at how vitamin d levels affect complication rates and hospital readmission rates.

Institution
MUSC
Recruitment Contact
Monica Baczko
843-792-8169
baczko@musc.edu

Maternal vs. Direct Infant Vitamin D Supplementation during Lactation RCT: Priming the Infant Immune System: Pilot Study Save

Date Added
January 5th, 2016
PRO Number
Pro00050609
Researcher
Carol Wagner
Keywords
Lactation, Vitamin D
Summary

Breastfeeding is important for the development of the immune system of the infant. Emerging data suggest that vitamin D plays an important role in immunity as well. Exclusively breastfeeding mothers and their infants will be studied in a 3-month (4-study visit) pilot study of vitamin D supplementation versus placebo. Longitudinal effects of vitamin D status on breast milk composition and on the infant's immune system will be examined.
Additionally, exclusively breastfeeding mothers who are currently on vitamin D supplementation will be studied at a single visit, at which mothers will provide a single breastmilk sample and have a single blood sample obtained. These samples will be used to examine effects of vitamin D supplementation on breast milk composition.

Institution
MUSC
Recruitment Contact
Nina Forestieri
843-792-2112
forestie@musc.edu

N-Acetylcysteine (NAC) and Vitamin-D in Hypoxic-Ischemic Newborns Treated with Hypothermia Save

Date Added
February 4th, 2014
PRO Number
Pro00031254
Researcher
Dorothea Jenkins
Keywords
Infant, Nervous System, Pediatrics, Stroke, Vitamin D
Summary

We propose to conduct a 1-year, two-center, open-label, non-randomized pilot trial to evaluate the disposition and safety of NAC in combination with Vitamin D in neonates who present within 6 hrs of hypoxia ischemia/asphyxial event and are receiving moderate hypothermia to 33 degrees C for 72 hours per standard protocol.

Institution
MUSC
Recruitment Contact
Kathryn Hope
843-792-2112
hopek@musc.edu

The role of Innate Immunity in the Development of Phenotypic Keloid Disease Save

Date Added
June 29th, 2013
PRO Number
Pro00019607
Researcher
Titus Reaves
Keywords
Immune System, Skin, Vitamin D
Summary

Keloid disease predominantly affects African Americans, Hispanics and some Asians. Keloid disease is characterized by an overgrowth of an area of the skin following some injury to that same skin area. It is unknown why this occurs. However, we believe that differences in Vitamin D along with dysfunction in certain immune system receptors can lead to keloid disease. To further understand this process we intend to study the cells (fibroblasts) in the skin that are affected by Vitamin D and examine the specific immune proteins.

Institution
MUSC
Recruitment Contact
Jacqueline Savage
(843) 792-9372; (843) 792-1870
savageja@musc.edu, reaves@musc.edu

Vitamin D3 Supplementation for Low-Risk Prostate Cancer, A Randomized Trial Save

Date Added
September 18th, 2012
PRO Number
Pro00019745
Researcher
Sebastiano Gattoni-celli
Keywords
Cancer, Prostate, Vitamin D
Summary

This randomized clinical trial will enroll 136 men recently diagnosed with Early-Stage prostate cancer. Men must be 19 or older with a prostate biopsy Gleason score ? 6 and PSA ?10 who have decided that active surveillance is their present treatment option. Study visits will be every 4 months for just over a year in Charleston, S.C. There will be two groups, one taking vitamin D3 supplement and the other taking a placebo. Assigment to each group will be by chance and neither the particpant nor the study team will know to which group they are assigned. Blood and urine samples will be collected at each visit for research purposes. A survey relating to the subjects' decision making about their biopsies will be completed at the baseline and final visits. Waist/hip ratio and blood pressure measurements will also be obtained at the baseline and final study visits. Each participant will be in the study until a repeat prostate biopsy is performed by their own Urologist as Standard of Care for Active Surveillance regimen.

Institution
MUSC
Recruitment Contact
Linda Ambrose
843-792-8303
ambrosel@musc.edu

Systemic Lupus Erythematosus in Gullah Health (SLEIGH) Save

Date Added
October 5th, 2009
IRB Number
10852
Researcher
Diane Kamen
Keywords
Autoimmune disease, Children's Health, Environmental Factors, Ethnicity and Disease, Healthy Volunteer Studies, Immune System, Joint, Kidney, Lupus, Minorities, Non-interventional, Vitamin D, Women's Health
Summary

The Systemic Lupus Erythematosus (SLE) in Gullah Health, or SLEIGH, study is an observational study enrolling African Americans from the Sea Island communities of South Carolina and Georgia. We are enrolling patients, family members of patients, and unrelated community members. SLE is a potentially severe disease that can affect the entire body. SLE is more common in African Americans than Caucasians. The main purpose of this study is to find genes that, along with factors from the environment, result in the development of SLE. Volunteers in SLEIGH will be asked to answer questions about their health and have blood and urine collected for tests. After the first visit there may be one additional visit 2 or more years later. This is not a drug study.

Institution
MUSC
Recruitment Contact
Stephanie Slan
843-792-8997
slans@musc.edu

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