Clinical Research Directory

Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients

A two arm pilot study investigating the rate of pathologic complete response in patients with vitamin D deficiency and triple negative breast cancer undergoing standard neoadjuvant chemotherapy + vitamin D supplementation, including an observational arm to describe response in patients who are not deficient. Investigators hypothesize that vitamin D supplementation during neoadjuvant chemotherapy in operable triple negative breast cancer patients with vitamin D deficiency will increase the rate of pathologic complete response chain reaction to that of vitamin D sufficient patients based on historical controls.

Vitamin D Status in Obstructive Sleep Apnea With and Without Comorbidities

This retrospective observational study evaluates the relationship between vitamin D status and obstructive sleep apnea (OSA) in adults. The study includes 269 participants divided into four groups: healthy controls, participants with simple snoring without OSA, patients with OSA without comorbidities, and patients with OSA with comorbidities. The main objective is to compare serum 25-hydroxyvitamin D \[25(OH)D\] levels among these groups and to examine whether vitamin D status is associated with the presence and severity of OSA. Demographic characteristics, body mass index, laboratory measurements, and available overnight polysomnography findings are evaluated using existing medical records. The study also examines the distribution of vitamin D deficiency across the study groups and the relationship between vitamin D categories and OSA severity.

Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

The investigators hypothesize that single oral high dose supplementation with vitamin A will reduce the incidence of moderate-severe chronic graft-versus-host disease (GVHD) compared with placebo.

Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)

This study is a double blind, placebo controlled, randomized trial of study subjects with PCOS and low vitamin D to 2 groups- placebo and vitamin D replacement. Participants and investigators will be blinded to treatment modality until the end of the trial period

Local and Systemic Inflammatory Bone Alterations Related to Dental Implant Survival.

Introduction: Dental implants offer a durable, aesthetic, and functional option for tooth replacement. However, they are not immune to failure. Current literature has highlighted the importance of systemic factors (such as vitamin D deficiency and osteoporosis) and local factors (such as the presence of nearby periapical infections or implant placement in sites with a history of endodontic failure) that affect bone health. Hypothesis: Bone alterations-whether systemic or local-represent a risk factor for implant failure and peri-implantitis. Objectives: To analyze implant failure and marginal bone loss in patients with local and/or systemic bone alterations compared to patients without such conditions. Methods: Implant failures occurring in patients treated within the Master's Program in Oral Medicine, Surgery, and Implantology at the University of Barcelona (MCIO-UB) over the last 10 years will be analyzed and correlated with bone factors (local and systemic) recorded in their medical histories. Cases lacking the radiographic and clinical data necessary to conduct the study will be excluded. Population: A total of 3,500 implants have been placed, with failure rates ranging from 4% to 8% depending on the techniques used; consequently, the study sample will consist of 192 implants. Cohorts of successful implants will be established by matching patients of the same sex and within a ±5-year age range who did not experience implant failure.

Vitamin D2 vs Vitamin D2 Plus Calcitriol in Cholestatic Children With Vitamin D Deficiency

The goal of this clinical trial is to learn whether adding calcitriol to vitamin D2 can improve vitamin D deficiency in children with cholestasis and chronic liver disease. Cholestasis is a condition in which bile flow is reduced, which can make it difficult for the body to absorb and process vitamin D. The study will also learn about the safety of using vitamin D2 together with calcitriol. The main questions it aims to answer are: * Does vitamin D2 plus calcitriol increase blood 25-hydroxyvitamin D (25-OHD) levels more than vitamin D2 alone after 3 months of treatment? * Does vitamin D2 plus calcitriol help more children reach an adequate vitamin D level by 3 and 6 months? * What medical problems, especially high calcium or high phosphorus levels, occur during treatment? Researchers will compare children who receive vitamin D2 alone with children who receive vitamin D2 plus calcitriol to see which treatment improves vitamin D levels more effectively and safely. Participants will: * Take vitamin D2 alone or vitamin D2 plus calcitriol as assigned by randomization * Visit the clinic for study assessments at the start of the study, at 3 months, and at 6 months * Have blood tests to measure vitamin D levels, calcium, phosphorus, parathyroid hormone, liver function, and other safety markers * Have their treatment reviewed at 3 months; participants whose vitamin D level remains low may have their treatment adjusted according to the study plan * Bring back medication packages so researchers can check how regularly the study medicines were taken

Vitamin D Status and Asthma Control, Pulmonary Function, and Oxidative Stress in Adults With Bronchial Asthma

Asthma is a chronic inflammatory airway disease associated with variable airflow limitation and persistent respiratory symptoms. Vitamin D has been proposed as a potential biomarker related to immune regulation, asthma control, pulmonary function, and oxidative stress balance. This prospective cross-sectional observational study aims to investigate the association between serum 25-hydroxyvitamin D \[25(OH)D\] concentrations, asthma control, pulmonary function parameters, and erythrocyte oxidative stress biomarkers among Egyptian adults with bronchial asthma. A total of 200 adult asthma patients will be recruited from Abbassia Chest Hospital, Cairo, Egypt. Participants will undergo clinical assessment, Asthma Control Test (ACT), post-bronchodilator spirometry, serum vitamin D measurement, and oxidative stress biomarker assessment including malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GPx), and reduced glutathione (GSH). Participants will be categorized according to serum 25(OH)D concentrations into vitamin D deficient, insufficient, and sufficient groups. No intervention or treatment assignment will be performed. 5\. Detailed Description

Effect of Systemic Vitamin D on Dental Implant Osseointegration

The primary goal for any oral implantologist is to obtain satisfactory healing and long-term treatment success. Osseointegration is the key to dental implant success8 and is required to achieve direct structural and functional connection between living bone and the surface of a load-bearing artificial implant, is critical for the long-term success of dental implants. Successful dental implant therapy relies on achieving proper osseointegration, which ensures a stable structural and functional bond between the implant surface and surrounding bone. Although dental implants show a high overall success rate of around 95%.

Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight

The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, immune system, and brain in extremely premature (EP) infants who are \<28 weeks gestational age (GA) or \<1000 grams of birth weight (BW). The study results will be analyzed as intention to treat Bayesian analyses (Frequentist analyses will also be performed).

ViDES Trial (Vitamin D Extra Supplementation)

The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, immune system, and brain in extremely premature (EP) infants who are \<28 weeks gestational age (GA) or \<1000 grams of birth weight (BW). The study results will be analyzed as intention to treat Bayesian analyses (Frequentist analyses will also be performed).

The Effect of Vitamin D Supplementation on the Anti-inflammatory Response in Periodontal Diseases

A review of the literature revealed that while there are studies investigating the relationship between vitamin D and periodontal disease, there are no studies investigating the anti-inflammatory effect of vitamin D on periodontal disease. Investigators hypothesized that the increased incidence of periodontal disease in individuals with vitamin D deficiency might be due not only to pro-inflammatory effects but also to impaired bone metabolism and a decrease in the anti- inflammatory mechanism. Investigators aimed to determine this by comparing serum and DOS levels of 1,25-dihydroxyvitamin D (1,25(OH)2D), 25-hydroxyvitamin D (25(OH)D3), Receptor activator nuclear kappa B ligand (RANKL), osteoprotegerin (OPG), Tumor Necrosis Factor Related Apoptosis induced Ligand (TRAIL), Developmental endothelial locus (Del)-1, Lipoxin, Resolvin, interleukin (IL)-10, and transforming growth factor-β (TGF-β). The study will include 120 individuals who are systemically healthy based on clinical and radiographic examinations and diagnosed with Stage I-II periodontitis, Stage III-IV periodontitis, chronic gingivitis, and periodontally healthy. Periodontal clinical parameters (Probing pocket depth (PPD), Clinical attachment level (CAL), Bleeding on probing (BOP), Plaque index (PI), Gingival index (GI)) will be recorded three times: before treatment, and 6 and 12 weeks after treatment. Gingival crevicular fluid (GCF) and serum samples will be collected from participants at baseline and 12 weeks later for biochemical analysis.

Bone Myoregulation Reflex and Postural Control in Vitamin D Deficiency

This observational study aims to investigate the relationship between vitamin D deficiency, postural stability, and neuromuscular control mechanisms in adults. The study will compare individuals with vitamin D deficiency and healthy controls. Participants will undergo a single-session evaluation including surface electromyography and postural stability assessments during standing tasks under different loading and vibration conditions. No invasive procedures, medications, or blood sampling will be performed. Previously obtained routine laboratory results will be used for vitamin D status. The study is designed to improve understanding of neuromuscular responses associated with vitamin D deficiency and to contribute to future rehabilitation strategies.

Clinical Comparative Evaluation of the Use of Photodynamic Therapy in Conjunction With the Use of Vitamin D in Management Stage II Grade B Periodontitis Patients

Clinical Comparative Evaluation of the use of Photodynamic Therapy in conjunction with the use of Vitamin D in management Stage II Grade B Periodontitis Patients: A Randomized controlled clinical trial.

Clinical Assessment of Adjunctive Omega-3 Versus Vitamin D Daily Supplements on Active Periodontal Therapy With Stage II Grade B Periodontitis Patients

Clinical Assessment of Adjunctive Omega-3 Versus Vitamin D daily Supplements on Active Periodontal Therapy with Stage II Grade B Periodontitis Patients: A Randomized controlled clinical trial.

A Household-Based Dietary Intervention Study of Vitamin D Fortified Bread in Irish Families

Vitamin D deficiency is common. It is caused by limited sun availability together with a low supply of vitamin D in the food system. There is a high prevalence of low vitamin D status around the world. In Ireland, our relatively northern latitude and prevailing weather mean that UVB availability for skin synthesis of vitamin D is limited in this country and our population relies on the dietary supply of vitamin D to prevent deficiency. Thus, the endemic Irish problem of vitamin D malnutrition is due to the lack of vitamin D in our food system. Dietary guidelines cannot address this issue because foods naturally rich in vitamin D are very few and infrequently consumed. The FamDBread study will test the hypothesis that a vitamin D-fortified bread as part of a healthy diet that includes vitamin D-fortified foods is effective in preventing low vitamin D status during winter, and safe for families to consume.

Vitamin D Sulfates in Breastmilk

Infants The purpose of this study is to measure breastmilk's vitamin D sulfate nutritional value in infant's saliva and digesta (gut). Breastfeeding Mothers The purpose of this study is to measure Vitamin D sulfates in freshly expressed breastmilk samples before and after 28 days of Vitamin D supplementation in lactating mothers.

Effect of Vitamin D on Postoperative Pain in Symptomatic Irreversible Pulpitis

Vitamin D deficiency (VDD) is a prevalent global health concern that has been linked to altered pain perception through its effects on inflammatory pathways, nociceptor activity, and neurotrophic signaling. While its role in chronic pain has been widely studied, limited evidence exists regarding its impact on acute postoperative dental pain. This triple-blinded randomized controlled clinical trial aims to evaluate the effect of moderate-dose vitamin D supplementation on postoperative pain following single-visit root canal treatment (RCT) in patients with symptomatic irreversible pulpitis affecting mandibular first molars. A total of 54 vitamin D-deficient patients (serum 25(OH)D \<30 nmol/L), aged 20-45 years, will be randomly allocated into three groups: a single preoperative dose group (150,000 IU vitamin D₃), a fractionated dose group (50,000 IU over three consecutive days), and a placebo group. All participants will undergo standardized single-visit RCT procedures. Postoperative pain will be assessed using a Modified Visual Analog Scale (VAS) at baseline and at 6, 12, 24, and 48 hours post-treatment, while analgesic intake will be recorded as a secondary outcome. It is hypothesized that vitamin D supplementation will significantly reduce postoperative pain levels and analgesic consumption compared to placebo. This study seeks to explore vitamin D as a safe, cost-effective adjunct in endodontic pain management, with potential implications for improving clinical outcomes in patients with VDD undergoing RCT.

Serum Vitamin D Status in Critically Ill Children With Acute Respiratory Infections

Acute respiratory infections (ARIs) are among the leading causes of hospitalization, morbidity, and mortality in children worldwide, particularly among critically ill patients admitted to pediatric intensive care units (PICUs). Vitamin D has an important role not only in bone metabolism but also in regulation of innate and adaptive immune responses, especially within the respiratory tract. Recent evidence suggests that vitamin D deficiency may be associated with increased susceptibility to respiratory infections, greater disease severity, prolonged hospitalization, and higher mortality rates in critically ill children. This observational cross-sectional study aims to assess serum vitamin D status among critically ill children admitted to the PICU with acute respiratory infections and to evaluate the relationship between vitamin D levels, severity of respiratory illness, and risk of mortality. The study will include pediatric patients aged 1 month to 16 years admitted to the Pediatric Intensive Care Unit of Assiut University Children's Hospital. Clinical evaluation and laboratory investigations, including serum 25-hydroxyvitamin D levels, serum calcium, and alkaline phosphatase, will be performed within the first 24 hours of admission. Severity of respiratory distress will be assessed using the Pediatric Respiratory Severity Score (PRESS), while mortality risk will be evaluated using the Pediatric Risk of Mortality Score (PRISM III). The findings of this study may contribute to better understanding of the role of vitamin D in critically ill children with respiratory infections and may support future strategies for early risk assessment and improved clinical management in pediatric intensive care settings.

Cholecalciferol in Newly Diagnosed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia With Vitamin D Deficiency

This randomized pilot early phase I trial studies how well cholecalciferol works in treating patients with newly diagnosed non-Hodgkin lymphoma or chronic lymphocytic leukemia with low levels of vitamin D (vitamin D deficiency). Cholecalciferol may increase levels of vitamin D and improve survival in patients with non-Hodgkin lymphoma or chronic lymphocytic leukemia receiving standard of care chemotherapy.

The Role of Urinary RhoA, NGF, and BDNF Levels in Overactive Bladder and Vitamin D Deficiency

The primary aim of this study is to evaluate the role of three specific urinary proteins-RhoA, Nerve Growth Factor (NGF), and Brain-Derived Neurotrophic Factor (BDNF)-as potential biomarkers for the diagnosis and follow-up of children aged 4-18 diagnosed with Overactive Bladder (OAB) and Vitamin D deficiency.

High-dose Vitamin D Supplements in Older Adults

This Phase II randomized clinical trial aims to test if supplementation with high dose oral vitamin D will successfully correct vitamin D insufficiency, compared to treatment with standard (RDA) dose vitamin D in a diverse community-based elderly cohort. The effect of high-dose vs. standard-dose vitamin D on altering cognitive trajectories will also be assessed and data will be expected to be used in designing a potential definitive Phase III trial in elderly groups at risk for dementia. A total of 180 elderly persons with longitudinal biomarkers, neuropsychological testing and brain MRI scans will be enrolled, with 152 (\~50 with MCI, 50 with mild AD and 50 with no cognitive impairment) expected to complete the 3½-year study. One-half of each diagnostic group will be randomized to treatment with high-dose vitamin D3 (4,000 IU daily) or to standard dose Vitamin D (600 IU capsule daily + \~200 IU dietary = \~800 IU total/day). Longitudinal MRI analyses will provide an estimate of the treatment effect size on brain atrophy rate. Vitamin D receptor genotype polymorphisms and their impact on response to oral supplementation will also be examined. If vitamin D supplementation improves cognitive outcome, this could have a large impact on the public health, since low vitamin D status is a common, readably treatable condition which may provide a novel window to prevent dementia and AD. Furthermore, the higher prevalence of AD and dementia in African Americans and Latinos could be partially attributable to vitamin D insufficiency.

Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D?

males with diabetes complain impotence in the presence of low vitamin D deficiency. pharacmological treatment of low vitamin D levels is necessary but changing lifestyle by performing exercise is also important

Comparison of Different Doses of Vitamin D Supplementation on Glycated Haemoglobin and Blood Glucose Parameters With Type II Diabetes Mellitus Having Vitamin d Deficiency

COMPARISON OF DIFFERENT DOSES OF VITAMIN D SUPPLEMENTATION ON GLYCATED HEMOGLOBIN (HbA1c) and BLOOD GLUCOSE PARAMETRS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS HAVING VITAMIN D DEFICIENCY"

Effect of Vitamin D Deficiency on the Frequency and Severity of Spinal Anesthesia-Induced Hypotension in Pregnant Women Undergoing Cesarean Section

Spinal anesthesia-induced hypotension remains a common and significant complication during cesarean sections, posing risks for both mother and fetus. Vitamin D deficiency, frequently observed in pregnant women, is associated with altered vascular function and potential hemodynamic instability. This prospective observational study aims to investigate whether vitamin D deficiency is associated with an increased incidence and severity of spinal anesthesia-induced hypotension in pregnant women undergoing elective cesarean delivery. Vitamin D levels will be measured preoperatively, and intraoperative hemodynamic parameters will be closely monitored. The findings could contribute to improved management strategies for pregnant patients at risk of severe hypotension.