Clinical Research Directory

Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid

The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6. The patients will be evaluated at baseline and after three months of treatment with placebo or product.

Does Vitamin C Increase the Body Heat Generated By The Nervous System?

The goals of this clinical trial are to determine whether or not vitamin C is able to: (1) increase the body heat generated by the sympathetic nervous system; and, (2) increase circulating vitamin D concentration during sympathetic nervous system stimulation in adult humans aged 18-40 years who meet the criteria for overweight based on body mass index. The main question it aims to answer are: 1. By how much does body temperature increase during stimulation of beta-adrenergic receptors when vitamin C is given. 2. By how much does circulating vitamin D concentration increase during stimulation of beta-adrenergic receptors when vitamin C is given. Participants will will be asked to: * undergo measures of body temperature * have blood sampled on two separate occasions: once during stimulation of beta adrenergic receptors, and once during stimulation of beta-adrenergic receptors while also been given vitamin C.

Exercise Training and Vitamin D Metabolism

The prevalence of Vitamin D deficiency is significantly higher in adults with overweight/obesity compared to those with normal body mass index (BMI). The "entrapment" of Vitamin D in adipose tissue due to impaired lipolytic stimulation and/or adipose tissue dysfunction has been proposed as the driving mechanism. Exercise training has been proposed as a promising strategy to increase mobilization of Vitamin D from adipose tissue, given its well described role in stimulating lipolysis. Indeed, a recent study revealed that participation in moderate-intensity cardiovascular type exercise over winter can mitigate the decline in 25-hydroxyvitamin D \[25(OH)D\] in adults with overweight/obesity, independent of weight loss. The aim of this study is to investigate the impact of hybrid-type high-intensity interval training over winter on vitamin D metabolism, in adults with overweight/obesity.

Vitamin D for Preventing Recurrent Preeclampsia in Pregnant Women

The goal of this clinical trial is to find out whether giving vitamin D to pregnant women who had pre-eclampsia in a previous pregnancy helps prevent the condition from coming back. The main question it aims to answer is: Does vitamin D supplementation reduce the chance of pre-eclampsia recurring in pregnant women with a history of pre-eclampsia? To answer this question, pregnant women attending the antenatal clinic at the Department of Obstetrics and Gynaecology, Nishtar Hospital Multan will be invited to join the study. Participants will be randomly assigned to two equal groups: * Vitamin D group: will take 4,000 IU of oral vitamin D until 36 weeks of gestation. * Placebo group: will receive a pill identical in appearance, taste, and consistency but without vitamin D. While on the study medication, each woman will visit the clinic every two weeks. At each visit, her blood pressure will be measured, and if it is 140/90 mmHg or higher, a urine test will check for protein to identify pre-eclampsia as per hospital protocol. Any diagnosis of pre-eclampsia will lead to standard care, and the outcome will be recorded. At the end, researchers will compare how many women in each group developed recurrent pre-eclampsia. This study will help answer whether vitamin D supplementation can safely reduce the risk of pre-eclampsia returning in women with a prior history - a question important for improving pregnancy outcomes and maternal health.

Free Vitamin D and Steroid Metabolism in Endocrine Disorders

This clinical study aims to gain a better understanding of how different forms of vitamin D are processed in the body in healthy individuals, pregnant women, and patients with various hormonal (endocrine) and kidney (renal) disorders. In the long term, this study may provide new insights that could how vitamin D is tested and interpreted in these groups. Vitamin D has several important roles in the body, such as building strong bones and maintaining calcium balance in the blood. Most vitamin D in the blood circulation is attached/bound to a protein called "vitamin D binding protein" (VDBP), which makes it unavailable for the body to use. A much smaller portion circulates freely in the blood and this is called "free vitamin D". This free form can be directly used by the body. When your doctor tests your vitamin D levels, this usually refers to total vitamin D (the sum of bound and free vitamin D). However, this total value may not give an accurate indication of your actual vitamin D status, since most of it (the bound part) cannot be used by the body. The purpose of this study is to examine whether "free vitamin D" is a better marker of vitamin D status and if the amount of free vitamin D differs between healthy people, pregnant women, and people with specific endocrine or kidney disorders. Additionally, this study will look into vitamin D metabolism more detailed, and investigate what different forms of vitamin D exist, how the body processes these, and whether these forms may be related to certain endocrine or kidney conditions.

Assessing Bone Fracture Healing Effect of Almonds

Femur and tibia shaft fractures are common after trauma with a burden of 5% and 20% respectively. Clinicians recommend costly bone strengthening drugs/supplements while treating bone fractures. These drugs have side effects and are costly due to which patients skip these supplements. Routinely prescribed vitamin D have known toxicity. To overcome this problem, affordable and safe alternative treatment is needed. Sweet almonds contain essential bone nutrients that might have potential for maintaining bone strength. Human and animal studies have shown positive impact of almonds on bone health and fracture healing. Almonds are consumed in diet frequently but may occasionally cause toxicity, mainly if consumed at higher amount. Because of the high bone essential nutrients in almonds, the trial aimed to investigate the fracture healing effect and safety of almonds in femur and tibia shaft fractures. This might provide an alternate option for bone supplants while treating fractures. Hypothesis: Compared to routine vitamin D3, almonds non-inferiorly improves fracture callus index and raise vitamin D3 level in blood in femur and tibia shaft fracture patients. Primary Objectives: 1. To compare tibia and femur shaft fracture callus index and callus bridging on x-rays at 4 and 13 weeks herewith group 1 suffering vitamin D insufficiency (arm A versus arm B) and group 2 suffering vitamin D deficiency (arm B versus arm C) treated as cross-over with oral whole almonds and vitamin D3. 2. To compare the incidence of adverse events between almonds and vitamin D3 treatments up to 13 weeks follow-up. Secondary Objectives: 1. To compare the almonds and vitamin D3 treatment cost. 2. To compare within group blood vitamin D levels (ng/mL) at baseline and post-treatment follow-ups. Methods: Study design: Single-center, open-labeled, crossover, non-inferiority randomized controlled trial. Total 136 subjects are required with 14 subjects in group 1 and 122 in group 2.in 24-month duration. Study procedures: 1. Regulatory and Ethical approvals. 2. Patient screening and eligibility assessment. Patients, of 18 to 55 years of age of any gender, with trauma associated femur and tibia shaft fractures who agree to voluntary participate are included and mentally retarded or patients with severe psychiatric illness, already on or require bone-strengthening drugs , having severe cardiovascular, hepatic, or renal disease, known allergy/toxicity to almonds and/or vitamin D supplements. 3. Written informed consent administration. 4. Randomization Patients (N=136) are divided into two groups. Group 1 (N=14, vitamin D insufficiency, blood vitamin D level 21-29 ng/mL) and Group 2 (N=122, vitamin D deficiency, blood vitamin D level ≤20 ng/mL). I. Group 1 (N=14): Arm A (n=7)=5 grams/day of almonds for 4 weeks, followed by 7 days washout period and cross-over treatment by oral vitamin D3 200,000 units/week for 8 weeks. Arm B (n=7)=Oral vitamin D3 200,000 units/week for 8 weeks, followed by 7 days washout period and cross-over treatment by 5 grams/day of almonds for 4 weeks II. Group 2 (N=122): Arm B (n=61)=Oral vitamin D3 200,000 units/week for 8 weeks, followed by 7 days washout period and cross-over treatment by 5 grams/day of almonds for 4 weeks. Arm C (n=61)=Oral vitamin D3 200,000 units/week together with 5 grams/day almonds for 4 weeks, followed by 7 days washout period and cross-over treatment by oral vitamin D3 200,000 units/week for 8 weeks. 5. Patients are followed at 4 weeks and 13 weeks follow-ups after treatment. 6. Fracture site routine X-rays and RUST scores are assessed by treating surgeon/investigator(s) at follow-ups for bone fracture healing. 7. Investigational product (IP) safety assessment and reporting as per ICH-GCP guidelines. Subjects experiencing any adverse event (AE)/serious adverse event (SAE) is provided optimum care at earliest. All relevant reporting bodies are notified within recommended timeline. 8. The almonds are regularly purchased from the Purchase Department of the Hospital, weighted, packaged and labelled, and stored at the secure dry hygienic place. The product is dispensed to the patient and a daily IP diary is provided for compliance. 9. Patients can withdraw from the study at any time without losing any of his/her patient rights. 10. Study close-out process will be of one to two-month duration. Statistical analysis: The SPSS version 19.0 will be used to analyze data. Quantitative variables will be expressed as mean±SD/median (IQR) and qualitative as frequencies (%). IP related AEs/SAEs will be assessed by incidence/stratification. Witin group and within arm comparisons for the radiological assessments and vitamin D3 level will be analyzed by ANOVA and GEE. Within arm tibia and femur fracture outcomes will be compared by independent t-test/Mann Whitney U test. The p-value \<0.05 is considered significant. Multiple regression analysis for association of covariates and outcome will be used.

Non-inferiority RCT on Fish Waste-Derived vs. Synthetic Vitamin D Supplementation in Healthy Adults With Suboptimal Vitamin D Levels

Vitamin D is a fat-soluble vitamin with hormone-like properties, essential for numerous physiological processes in humans. It plays a central role in maintaining calcium and phosphorus homeostasis, promoting intestinal absorption of these minerals, and ensuring optimal bone mineralization. There are two main forms: vitamin D2 (ergocalciferol), primarily obtained from plant sources and supplements, and vitamin D3 (cholecalciferol), synthesized endogenously in the skin through exposure to ultraviolet B (UVB) radiation and present in animal-derived foods such as fatty fish, liver, and egg yolks. Beyond its well-known skeletal functions, vitamin D contributes to muscle contraction, immune system modulation, and regulation of cell proliferation and differentiation. Increasing evidence suggests that adequate vitamin D status may benefit cardiovascular health, glucose metabolism, and possibly reduce the risk of certain cancers, while supplementation has been associated with improved plasma lipid profiles, a relevant factor in cardiovascular risk reduction. The European Food Safety Authority has authorized various health claims for vitamin D, including its role in normal calcium and phosphorus absorption and utilization, maintenance of normal blood calcium concentrations, bone and teeth health, normal muscle function, immune defense, and reduction of the risk of falls in older adults. Despite its importance, vitamin D deficiency is recognized as a widespread public health concern across Europe, with prevalence influenced by latitude, season, skin pigmentation, and lifestyle habits. Data indicate that up to 40% of Europeans have suboptimal vitamin D levels, with deficiency rates exceeding 70% in specific high-risk groups such as elderly individuals, people with dark skin, and those with limited sun exposure. In Italy, despite abundant sunlight, vitamin D insufficiency is highly prevalent, particularly in older adults and patients with chronic illnesses. Contributing factors include urbanization, sedentary lifestyles, reduced time spent outdoors, and cultural or clothing practices limiting sun exposure. Approximately half of the Italian population is estimated to have insufficient vitamin D levels, with rates rising in the northern regions during winter months. Prolonged deficiency has severe consequences for skeletal health, including rickets in children, osteomalacia in adults, and increased risk of osteoporosis and fractures. It is also linked to a broad range of extra-skeletal effects, such as impaired immune response with greater susceptibility to infections, increased risk of chronic diseases including cardiovascular disorders, type 2 diabetes, and certain cancers, as well as muscle weakness, higher likelihood of falls, and mood disorders such as depression and seasonal affective disorder. Addressing vitamin D deficiency requires a multifaceted approach involving dietary supplementation, food fortification strategies, and public health initiatives promoting safe sunlight exposure. Severe deficiency requires pharmacological treatment with appropriately dosed medications, whereas mild deficiency can be corrected through over-the-counter supplements. In Italy, vitamin D supplements contain up to 2000 IU per day, with the recommended daily allowance for healthy adults set at 600 IU. The demand for vitamin D supplementation is reflected in market trends: the global market was valued at USD 1.69 billion in 2022 and is projected to reach USD 3.44 billion by 2031, with an estimated compound annual growth rate of 8.22% between 2023 and 2031. Against this background, the exploration of natural, sustainable sources of vitamin D, particularly from food industry by-products such as fish waste, offers an environmentally friendly alternative to synthetic forms currently dominating the market. This concept underpins the PRIN research project "Innovative and sustainable processes for the development of Vitamin D nutraceutical from fish waste: extraction, formulation and clinical study for the evaluation of its bioavailability and clinical consequence" (VITADWASTE; 2022M9JL3%; National Coordinator: Prof. Gianni Sagratini, University of Camerino), supported by the Italian Ministry of University. The project aims to develop and clinically evaluate a fish-derived vitamin D nutraceutical as a sustainable solution. Within this context, the primary objective of the present randomized, double-blind, non-inferiority clinical trial is to assess whether supplementation with fish-derived vitamin D at a dose of 600 IU per day, corresponding to 100% of the recommended daily intake for healthy adults, has an effect on plasma vitamin D levels comparable to that of an equivalent dose of standard synthetic vitamin D in healthy adults with mild vitamin D deficiency, defined by plasma concentrations between 20 and 40 ng/mL.

Efficacy and Safety of Vitamin D Supplementation in Pediatric Patients with Obesity

Introduction: Vitamin D deficiency is commonly observed in patients with obesity, primarily due to sequestration by adipose tissue. Recent research highlights the importance of this deficiency, showing a correlation between low vitamin D levels and mechanisms contributing to insulin resistance. Objectives: This study aims to compare the effects of supplementing with 4,000 IU of vitamin D versus 1,000 IU over six months on insulin resistance and the leptin/adiponectin ratio in school-aged children and adolescents with obesity. Materials and Methods: A controlled clinical trial will be conducted involving 40 children with obesity aged 10 to 18 years (BMI \>95th percentile). Participating children and their parents will undergo measurements such as weight, height, BMI, body fat, and Tanner stage. All participants will receive dietary and physical activity recommendations based on WHO guidelines. After initial assessments, participants will be randomly assigned to receive either 4,000 IU or 1,000 IU of vitamin D. They will be monitored monthly for capsule intake and adverse effects, with follow-up measurements of anthropometry, leptin, adiponectin, insulin \& lipid profile. Statistical Analysis: Baseline characteristics will be compared using t-Student or U-Mann Whitney tests, depending on variable distribution. The intervention's impact will be assessed by calculating deltas for body fat and biochemical measurements, with significance tested using paired t-tests or Wilcoxon tests. Covariance analysis (ANCOVA) will be used to adjust for confounding variables.

Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer

This randomized controlled Phase III trial was designed to evaluate the impact of supplemental vitamin D (VD) on the efficacy and side effects of neoadjuvant therapy in patients with breast cancer.

Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer

This randomized controlled Phase III trial was designed to evaluate the effect of vitamin D supplementation (VD) on chemotherapy side effects following adjuvant chemotherapy in breast cancer