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Vitamin D Deficiency clinical trials

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NCT ID: NCT01910792 Completed - Clinical trials for Vitamin D Deficiency

Ultraviolet Light And Vitamin D In Subjects With Fat Malabsorption Or After Gastric Bypass Surgery

Start date: March 2011
Phase: N/A
Study type: Interventional

Patients with fat malabsorption due to Crohn's disease, ulcerative colitis, or other causes including cystic fibrosis, among others, or who have undergone gastric bypass have increased incidence of vitamin D deficiency relative to the general population. Given that vitamin D is fat soluble and absorbed in the proximal small intestine, it has been documented that vitamin D deficiency in people with a fat malabsorption syndrome is due to decreased absorption of vitamin D. The amount of vitamin D produced from winter sunlight (in Boston, MA) and dietary sources will negligibly raise blood vitamin D levels in these patients, and oral vitamin D supplementation may have limited efficacy due to malabsorption. A variety of UV light sources have been developed and sold as in-home tanning devices and to produce vitamin D in reptiles. The efficacy of correcting vitamin D deficiency by the skin exposure to an artificial source of UVB radiation in patients with fat malabsorption syndromes (Crohn's disease, ulcerative colitis, or cystic fibrosis) or after gastric bypass surgery has not been studied. The investigators have conducted a pilot study in healthy adults that demonstrated that exposure to the lamp raised the blood level of 25-hydroxyvitamin D with no side effects. The main purpose of this study is to evaluate the effect of the FDA approved artificial source of ultraviolet (UVB) radiation (Sperti® lamp) in improving vitamin D status in patients with fat malabsorption syndromes and patients who have undergone roux-en-Y gastric bypass surgery.

NCT ID: NCT01909063 Completed - Clinical trials for Vitamin D Deficiency

A Randomized Controlled Trial Testing The Effect Of A Multi-Nutrient Fortified Juice

Start date: January 2005
Phase: N/A
Study type: Interventional

The goal of this investigator-initiated study is to determine whether the fortification of orange juice with vitamin D, vitamin A, and vitamin E will enhance the vitamin D, vitamin A, and vitamin E status children ages 6-10 that are seen at the Division of Pediatrics at Boston University Medical Center. Circulating concentrations of 25-hydroxyvitamin D [25(OH)D], vitamin A, and vitamin E before, will be measured at mid-intervention (week 6), and after a period of twelve weeks. This study plans to recruit 180 male and female subjects between the ages of 6 and 10. An informed consent will be explained and discussed with the subjects and their parents/guardians willing to participate in the study. The study will be twelve weeks. Blood will be drawn during the initial visit, mid-intervention (week 6), and week 12. Dietary intake will be assessed at baseline and at the conclusion of the 12-week intervention using a 3-day food record. The subjects will be randomized in a double-blinded manner via an electronically shuffled listed. Subjects will be randomized to receive one of three beverages: (1) calcium plus vitamin D fortified orange juice (intervention A), (2) calcium plus vitamins D, A, and E fortified orange juice (intervention B) or (3) calcium-only fortified orange juice (controls). Subjects in all groups will drink two 8-oz. glasses of juice at least six hours apart (morning and afternoon) per day for a period of 12 weeks. Subjects randomized to intervention A will receive 200 IU vitamin D and 700 mg of calcium per day in 2 glasses of juice, intervention B will receive 200 IU vitamin D, 12 IU vitamin E, 2000 IU vitamin A as beta carotene, and 700 mg of calcium per day in 2 glasses of juice, while controls will receive 700 mg of calcium per day in 2 glasses of juice. A blood sample will be obtained before the subjects begin drinking the orange juice and at week 12 to determine levels of 25(OH)D which is a measure of vitamin D status. Blood will also be used for determining osteocalcin, parathyroid hormone (PTH), alkaline phosphatase, phosphorus, calcium, C-telopeptide (CTX), albumin, vitamin A, and vitamin E. A blood sample will also be obtained at week 6 for 25(OH)D and PTH.

NCT ID: NCT01896544 Completed - Hypovitaminosis D Clinical Trials

Cholecalciferol Supplementation for Sepsis in the ICU

CSI
Start date: January 2014
Phase: Phase 3
Study type: Interventional

Sepsis in a clinical entity that occurs in patients with serious infections. Though the severity of illness may vary, every year, approximately 1.6 million Americans are treated for sepsis. Even with timely interventions, anywhere from 16% to >80% of patients with sepsis will not survive. Immune dysfunction is thought to play a critical role in the ability for infections to evolve into sepsis and to eventually lead to death. Recently, vitamin D has been identified as a key regulator of the immune system. While it remains unclear whether optimizing vitamin D status may improve outcomes in sepsis, little is known about the effects of vitamin D supplementation in patients with severe infections. As such, our goal is to study whether high doses of cholecalciferol (vitamin D3) can improve vitamin D status and boost certain aspects of the immune system in patients with sepsis.

NCT ID: NCT01893385 Terminated - Clinical trials for D Vitamin Deficiency Patients

Vitamin D Supplementation and the Immune Response

Start date: June 2013
Phase: Phase 2
Study type: Interventional

The main objective is to assess the variation in plasma levels of cathelicidin before and after influenza vaccination. All bibliographic data suggests that supplementation vitamin D in the elderly often deficient in this vitamin may have a double interest: - By induction of cathelicidin, assist in anti-infective response in particular to the influenza virus - The normalization of vitamin D status, promote the return to an appropriate immune response limiting excess inflammation and improving capacity to respond. The entire project will collect new information on the merits of the use of vitamin D in aging. A better knowledge of mechanisms involved and the impact of aging on them is a necessary prerequisite the definition of a new strategy using this drug in the elderly particularly fragile in order to improve its autonomy. This definition seems a sociological interest obvious economic knowing the current aging population and its impact future of our health system.

NCT ID: NCT01877577 Completed - Clinical trials for Ulcerative Colitis (UC)

Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D

Start date: April 2012
Phase: N/A
Study type: Interventional

This study aims to evaluate the effect of vitamin D3 supplementation on disease activity and quality of life in IBD patients deficient in vitamin D, and also help determine the optimal dose of vitamin D3 for them. Hypothesis: Supplementation of vitamin D3 in IBD patients with hypovitaminosis D can improve their quality of life and decrease IBD activity.

NCT ID: NCT01858051 Withdrawn - Hypovitaminosis D Clinical Trials

Vitamin D Status in Lower Extremity Joint Replacement Surgery Patients

Start date: January 2015
Phase: N/A
Study type: Interventional

In the United States, ~1 million elective hip or knee replacement surgeries are performed annually. With estimated surgical site infection (SSI) rates as high as 2.5%, this represents ~25,000 patients at risk of potentially avoidable morbidity following lower extremity joint replacement surgery. Although SSIs only account for 20% of all HAIs, they are a major risk factor for prosthetic joint infections (PJIs). Furthermore, UTIs have also been identified as an independent risk factor for infections of implanted hardware. In general, the majority of PJIs become apparent within 3 months of hardware implantation, but deep infections may not be evident for up to one year after surgery. Hardware infections result in delayed healing, repeated surgical interventions, and long-term antibiotic therapy. PJIs are associated with an average increase in hospital LOS by 14 days, additional expenditures of up to $50,000 per infected joint, and a doubling of the mortality rate compared to uninfected lower extremity joint replacements. Recent work from our group suggests that vitamin D insufficiency may be a risk factor for perioperative HAIs. The prevalence of vitamin D insufficiency is approximately 40% in elective joint replacement surgery patients, and perioperative 25(OH)D levels drop 30-40% in the setting of surgical stress, remaining 20% below baseline up to 3 months after surgery. To date, perioperative vitamin D optimization strategies have not been reported. Therefore, our goal is to study the effect of a single (pre-operative) versus a divided (pre-operative and on post-operative day 1) dose of cholecalciferol on perioperative vitamin D status in patients scheduled for elective hip or knee joint replacement surgery.

NCT ID: NCT01855321 Completed - Type 2 Diabetes Clinical Trials

Effects of Treating Vitamin D Deficiency in Poorly Controlled Type 2 Diabetes

Start date: August 2010
Phase: Phase 1
Study type: Interventional

This pilot study will investigate the effect of Vitamin D supplementation in improving glucose control with patients with poorly controlled diabetes and concurrent Vitamin D deficiency.

NCT ID: NCT01848236 Completed - Clinical trials for Vitamin D Deficiency

Effects of Vitamin D Insufficiency in Man

Start date: August 2010
Phase: N/A
Study type: Interventional

We would like to determine if vitamin D insufficiency exists in different ethnic groups, if it has an effect on bone mass and muscle function, if it has an impact on the function of the cells of the immune system, and if the functioning level of these systems can be improved by stabilizing the vitamin D levels to within normal limits.

NCT ID: NCT01845142 Completed - Clinical trials for Vitamin D Deficiency

Immunologic Action of a Single Dose Cholecalciferol

ViDImmun
Start date: February 2013
Phase: Phase 4
Study type: Interventional

Vitamin D receptors are expressed in activated different immune cells. It is not known, which immune cell type is targeted by exogenous vitamin D. Here, vitamin D-deficient individuals will receive once 100.000 I.U. vitamin D3 either intramuscular or subcutaneous in a double-blind placebo controlled setting. Immune cells will be monitored from the blood over time.

NCT ID: NCT01838447 Completed - Clinical trials for Vitamin D Deficiency

Prevention of Vitamin D Deficiency Following Pediatric CHD Surgery: a Phase II Dose Evaluation Randomized Controlled Trial Comparing Usual Care With a High Dose Pre-operative Supplementation Regimen Based on the Institute of Medicine Daily Upper Tolerable Intake Level

HICCUPS 2
Start date: July 2013
Phase: Phase 2
Study type: Interventional

Our research group has shown that almost all children with congenital heart disease (CHD) are vitamin D deficient following heart surgery. This work strongly suggests that the vitamin D intake presently recommended for healthy children, and also given to children with CHD, is inadequate to prevent vitamin D deficiency following surgery. Unfortunately, there have been no studies investigating any other vitamin D dose in children with heart disease. Recently, a higher dose of vitamin D intake has been approved (by the Institute of Medicine and Health Canada) and recent work on healthy children has shown it to be safe. The objective of this study is to determine whether this recently approved higher dose of vitamin D can safely reduce the number of children who are vitamin D deficient following surgery. This dose evaluation study will also evaluate whether it is possible to perform a large study (across Canada) to determine whether vitamin D supplementation can improve outcomes following surgery. It is hypothesized that a daily high dose vitamin D regimen, modeled on the Institute of Medicine daily upper tolerable intake level (UL), will significantly reduce vitamin D deficiency following CHD surgery, when compared with usual intake.