Vitamin D

Researchers are studying vitamin D levels in hospitalized individuals with neurological disorders that cause motor disabilities. The goal is to gather important data to help create guidelines for vitamin D use in these populations, including people with stroke, spinal cord injury, and traumatic brain injury. The study also aims to evaluate how vitamin D supplements affect bone density, body composition, strength, walking speed, physical performance, and pain. The study is a two-year randomized, controlled trial enrolling 120 participants, including 30 controls. Participants with low vitamin D levels will receive vitamin D supplements either as 50,000 I.U. weekly for 8 weeks or 25,000 I.U. for 4 weeks followed by 10,000 I.U. drops weekly for another 4 weeks. Controls have vitamin D levels above 20 ng/ml and do not receive supplementation. Measurements include serum vitamin D and related biochemical markers, assessed at the start and end of the study. Participants will undergo various assessments such as bone density scans using DXA, strength tests with a dynamometer, walking speed tests, physical performance evaluations with the SPPB test, and pain scoring. Demographic data and lifestyle factors like exercise and smoking will also be recorded. Safety and tolerance of vitamin D supplementation will be monitored. The primary outcome is the number of participants with neurological disease and low vitamin D levels, with secondary outcomes including improvements in structural and functional parameters due to supplementation.

Researchers are studying individuals with bone and mineral disorders to better understand these conditions and improve knowledge about bone biology. The study allows patients with various skeletal diseases to be evaluated and treated at the NIH Clinical Center, while also offering training opportunities for NIH trainees. The research includes collecting bone specimens from patients to support further study of bone diseases. Participants receive evaluations that include medical history reviews, physical exams, and standard tests such as blood and urine analysis, X-rays, bone densitometry, bone scans, CT scans, and MRI. Bone samples may be collected either from tissue removed during planned surgical procedures or via bone biopsy as part of the evaluation. No experimental treatments or tests are involved; all procedures are part of routine care for skeletal diseases. Throughout the study, patients undergo clinical assessments tailored to their diagnosis at specific times. Researchers collect and analyze clinical data and biological specimens, including genetic and biochemical tests on surgical waste material. The study aims to build a database containing detailed information and specimens from participants to support future research. Participation duration and specific assessments vary depending on each participant's condition and needs.

Researchers are investigating the effects of sweet almonds on healing femur and tibia shaft fractures compared to routine vitamin D3 supplements. This study addresses the need for an affordable and safe alternative to bone-strengthening drugs, which often cause side effects and are costly. The trial focuses on patients with vitamin D insufficiency or deficiency, assessing the potential of almonds to improve bone healing and vitamin D levels in the blood. The trial is a single-center, open-label, crossover randomized controlled study involving 136 participants aged 18 to 55 with trauma-related femur and tibia shaft fractures. Participants are divided into two groups based on their vitamin D levels and receive treatments including daily whole almonds (5 grams/day) and weekly oral vitamin D3 (200,000 units) in various sequences with washout periods. Group 1 includes vitamin D insufficient patients receiving almonds and vitamin D3 in a crossover design, while Group 2 includes vitamin D deficient patients receiving vitamin D3 alone, almonds alone, or a combination followed by crossover treatments. Participants undergo follow-up visits at 4 and 13 weeks post-treatment, where fracture healing is monitored through routine X-rays and Radiological Union Score for Tibial fractures (RUST). Safety is closely assessed, with adverse events recorded and managed according to international guidelines. The study also tracks treatment adherence with daily diaries and compares costs and changes in blood vitamin D levels. Patients may withdraw at any time without losing their rights, and the study will be completed within 24 months including a close-out period.

This research focuses on understanding the effects of sleeve gastrectomy, a popular weight loss surgery, on bone and muscle health in adults with obesity. It compares changes in bone mineral density and muscle mass over three years among men, premenopausal women, and postmenopausal women who undergo the surgery, against similar individuals who do not have the surgery. The study aims to assess the risks of bone loss and muscle strength reduction that may occur after this procedure, which is important given concerns about fractures and falls following older types of bariatric surgeries. Participants are divided into four groups: men, premenopausal women, postmenopausal women undergoing sleeve gastrectomy, and a non-surgical group of obese individuals. The study observes changes in spine and femur bone density using quantitative computed tomography and dual-energy X-ray absorptiometry, alongside assessments of muscle mass, quality, and strength. Measurements are taken before surgery, then one year and three years after surgery, to track progress and compare results between surgical and non-surgical groups. Throughout the study, participants will undergo scans and tests to measure bone density and muscle condition, including physical performance evaluations that predict risk of falls and fractures. These assessments are planned at baseline, 1 year, and 3 years after surgery. Researchers monitor changes over time to understand the long-term impact of sleeve gastrectomy on bone and muscle health. The total participation time spans three years, with ongoing evaluation of outcomes related to bone mineral density and muscle mass at specific skeletal sites.

Researchers are studying the effects of sleeve gastrectomy, a popular weight loss surgery, on bone health in adults with type 2 diabetes. The study aims to see how this surgery impacts volumetric bone mineral density (vBMD) and to compare these effects with those in obese patients without diabetes and overweight individuals without diabetes or obesity. The goal is to understand how diabetes and bariatric surgery together affect bone strength over time. The study is observational and includes two groups: 70 adults with obesity undergoing sleeve gastrectomy, some with type 2 diabetes and some without, and 30 overweight adults without diabetes serving as controls. Participants in the surgery group are evaluated before surgery and again at 4 months, 8 months, 1 year, and 3 years after the procedure. The control group is assessed once. The main treatment studied is the sleeve gastrectomy surgery, and its impact on bone and metabolic health is monitored. Participants will undergo various tests and assessments including quantitative computed tomography (QCT) scans to measure bone density at the spine, hip, tibia, and radius before surgery and during follow-up visits. Blood tests will track bone turnover markers, glucose control, and hormone levels. Body composition, muscle strength, physical activity, nutrition, and gut microbiota will also be measured at multiple timepoints. Researchers will monitor changes over three years to evaluate long-term bone health and related factors in this population.

Researchers are evaluating the link between vitamin D deficiency, postural stability, and neuromuscular control in adults aged 20 to 40 years. This observational study compares individuals with vitamin D deficiency to healthy controls to better understand how vitamin D status affects neuromuscular responses and balance. Participants are divided into two groups based on routine clinical test results for vitamin D levels. Those with vitamin D deficiency and those with normal vitamin D status both undergo a single session of non-invasive assessments. These include surface electromyography to measure muscle activity and tests of postural stability during various standing tasks, including single-leg and double-leg stance with and without vibration stimulation. During the single assessment session, researchers will record muscle activation and postural stability parameters under different conditions. They will analyze neuromuscular reflexes and how loading and vibration influence balance. The study aims to provide insights for future rehabilitation and balance training strategies. Participation involves no invasive procedures, medications, or additional blood tests, and results from prior routine labs are used to determine vitamin D status.

This research aims to understand the relationship between vitamin D levels, bone metabolism, and obesity in children aged 3 to 15 years who have experienced low-energy trauma. The study compares children with confirmed fractures to those with similar trauma but no fractures to explore factors that may contribute to bone fragility and fracture risk. Participants are divided into two groups: children with radiologically confirmed low-energy fractures and children with low-energy trauma but no fractures. Blood samples are collected within seven days of trauma to measure markers such as 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase, calcium, and phosphate. Dietary calcium intake and body measurements are also recorded to evaluate nutritional and metabolic status. Children will undergo baseline assessments including body mass index measurement and a dietary questionnaire. Researchers analyze blood markers and calculate a composite bone risk score to identify factors linked to fracture risk. The study uses statistical methods to compare groups and assess the association between bone markers and fractures, aiming to improve understanding of pediatric bone health and inform prevention strategies.

Researchers are studying adults with hypovitaminosis D, a condition characterized by low vitamin D levels in the blood. This randomized clinical trial compares three different ways of taking vitamin D supplements to see how well they raise vitamin D levels and affect bone mineral density. The purpose is to find the best dosing method for improving vitamin D intake. Participants are assigned to one of three treatment groups: Group A receives 0.266 mg of calcifediol once a month, Group B takes 25,000 IU of cholecalciferol every 15 days, and Group C uses 4 drops of calcifediol daily. Vitamin D blood levels are measured after one month of treatment to guide dosing. The study also monitors bone mineral density over an 18-month period. During the trial, participants have their vitamin D levels checked at one and six months after starting treatment. Bone density is assessed using DEXA scans between recruitment and 18 months. The study involves randomization and single masking to monitor and compare the effects of these vitamin D supplementation methods. Participation lasts up to 18 months, including follow-up assessments.

This trial studies adults aged 18 to 40 years with a body mass index indicating overweight to see if vitamin C can increase the heat produced by the sympathetic nervous system and raise vitamin D levels during nervous system activation. It aims to find out how much body temperature and circulating vitamin D change when beta-adrenergic receptors are stimulated with and without vitamin C. Participants visit the lab twice where beta-adrenergic receptors are stimulated using isoproterenol. One visit includes isoproterenol with saline only, and the other includes isoproterenol with saline and vitamin C. The order of these visits is randomized. Body temperature is measured with a thermometer and thermal camera, and blood samples are taken to measure vitamin D levels. During the study, participants undergo body temperature measurements and blood draws at baseline and after doses of isoproterenol at 30, 60, and 90 minutes. Researchers monitor changes in temperature and vitamin D concentration to assess the effect of vitamin C during stimulation. The total participation involves two lab visits with these assessments and monitoring under medical supervision.

Recent research shows vitamin D deficiency is common in critically ill patients, leading to longer ICU stays, higher costs, and increased risk of infections and death. This trial aims to evaluate early vitamin D3 supplementation in critically ill patients with low vitamin D levels to maintain sufficient serum calcidiol levels. Conducted across multiple centers in Taiwan, the study seeks to inform guidelines for vitamin D dosing based on deficiency severity. Participants will receive vitamin D3 or a placebo (medium-chain triglyceride supplement) based on their initial serum 25(OH)D levels. Supplement doses vary accordingly, with vitamin D3 given in high doses starting on ICU day 3, administered every 3 hours over 48 hours. Serum calcidiol and parathyroid hormone levels will be measured on Days 0, 7, 14, and 30 to monitor response. During the study, 240 critically ill patients will be closely monitored for vitamin D levels and clinical outcomes, including 30-day mortality. Additional assessments include length of ICU and hospital stay, mortality related to vitamin D levels, and correlations between vitamin D increments and body weight. This comprehensive monitoring will help determine the best vitamin D treatment strategy for critically ill patients over the 30-day period following ICU admission.