Clinical Research Directory

Effect of Vitamin C on Length of Hospital Stay in Children With Severe Pneumonia

Severe pneumonia is a common and serious illness in young children and often requires hospital admission. This clinical trial aims to find out whether adding vitamin C to standard treatment can reduce the length of hospital stay in children under five years of age admitted with severe pneumonia. The main question this study seeks to answer is: Does giving vitamin C along with routine treatment help children with severe pneumonia recover faster and go home earlier compared to standard treatment alone? In this study, 90 children aged 2 to 59 months who are admitted to the Children's Hospital Multan with severe pneumonia will take part. Severe pneumonia is defined by fast breathing, fever, cough, and one or more danger signs such as difficulty feeding, repeated vomiting, seizures, bluish discoloration of lips, or noisy breathing. Children with chronic lung disease or weakened immunity will not be included. After parental consent, children will be randomly divided into two groups. One group will receive standard treatment only, which includes oxygen therapy and intravenous antibiotics according to hospital protocol. The second group will receive the same standard treatment plus a daily dose of vitamin C. Neither group will receive any experimental or unapproved therapy. Researchers will closely monitor each child's recovery, including improvement in breathing rate, temperature, oxygen levels, and overall clinical condition. The child will be discharged when the treating physician determines that recovery criteria are met. The number of days spent in the hospital from the start of treatment until discharge will be recorded. By comparing the average hospital stay between the two groups, this study aims to determine whether vitamin C is a useful and safe add-on treatment for severe pneumonia in young children. The findings may help improve care and reduce hospital stay for children with severe pneumonia in the future.

High - Dose Vitamin C Infusion Regimen Based on Pharmacokinetic Characteristics for Patients With Advanced Malignant Solid Tumors

Vitamin C is an essential water - soluble vitamin for the human body. It plays an important role in various physiological processes as an antioxidant and cofactor for multiple enzymes. Most vertebrates can synthesize vitamin C by themselves, but humans can only obtain it from the diet due to inactivating mutations in the synthesis enzyme gene. The incidence of severe malnutrition in tumor patients is 58.2%, and they often have insufficient intake. Vitamin C can be used for the prevention and treatment of various diseases, including vitamin C deficiency, iron - deficiency anemia, atherosclerosis, and COVID - 19. Its role in anti - tumor treatment was first proposed by Cameron E and Pauling LN in the 1970s. However, it was not verified in a subsequent randomized controlled study at the Mayo Clinic, and this treatment has been controversial ever since. Until subsequent studies found that this difference may be due to different administration routes. Oral administration is limited by absorption, transportation, and metabolism. Even at the maximum tolerated dose, the plasma drug concentration is always \< 250 μmol/L, while intravenous injection can safely reach a pharmacological plasma concentration of 25 - 30 mmol/L, which is the key to exerting the anti - tumor effect. Therefore, intravenous injection of high - dose vitamin C (HDVC) as an emerging anti - tumor therapy has received renewed attention. A series of clinical studies have confirmed that a dose of 75 - 100 g/day (1.5 - 2.2 g/kg) is safe. Most pre - clinical experiments suggest that HDVC can inhibit the development or metastasis of tumors, significantly improve the survival rate of experimental animals, and prolong their survival time. It also has a synergistic or sensitizing effect on chemotherapy, radiotherapy, and targeted therapy. However, the number of clinical trials with positive results is very limited. Only a small number of studies have reported trends of increased disease control and objective response rates. For example, when combined with gemcitabine in the treatment of pancreatic cancer, the overall survival (OS) and progression - free survival (PFS) of patients were prolonged (21.7 months vs. 11.1 months; 13.7 months vs. 4.6 months). Currently, all clinical trials lack standardization and normativity in efficacy detection, and the repeatability of the experiments is poor. This has led to a situation where pre - clinical research shows good results, but clinical translation is very difficult. This may be closely related to the pharmacokinetic characteristics of vitamin C: a short half - life of only 30 minutes, high lability, first - order kinetic elimination, and rapid excretion through the kidneys. It is easily metabolized by the body's antioxidant system (especially reduced glutathione). After the infusion stops, the plasma vitamin C concentration drops rapidly, resulting in insufficient duration of the drug peak concentration or effective concentration to kill tumor cells in the body. Therefore, ensuring sufficient blood drug concentration, prolonging the duration of the effective concentration, and inhibiting the metabolism of antioxidants may improve the therapeutic effect of HDVC. This study attempts to summarize the clinical synergistic strategies of HDVC from existing clinical trials and explore a better HDVC treatment regimen. Based on comprehensive clinical research, we take patients with advanced malignant solid tumors receiving systemic anti - tumor treatment as the research objects. While patients are undergoing systemic anti - tumor treatment, HDVC treatment is combined. Three cohorts are designed: 0.5 g/kg once a day; 0.5 g/kg twice a day; 0.75 g/kg twice a day. All are intravenously dripped continuously for 5 - 7 days during the first cycle of standard systemic anti - tumor therapy, and the blood concentration of vitamin C is detected daily. The main objectives of this study are to study the pharmacokinetic characteristics of different high - dose vitamin C intravenous drip regimens in patients with advanced solid tumors, evaluate whether twice - daily administration can increase the blood concentration of vitamin C, and explore the appropriate regimen for combining high - dose vitamin C intravenous drip with standard systemic therapy in treating patients with advanced malignant solid tumors, providing ideas and a basis for the standardized clinical application of HDVC in the future.

Dietary Supplements in Patients With Coronary Artery Bypass Grafting for Improving the Quality of Healthcare Delivery.

Cardiovascular disease (CVD) remains the leading cause of death worldwide. Prevention of CAD by targeting modifiable factors remains a key public health priority. L-Ascorbic Acid (Vitamin C - Vit. C) and Omega 3 fatty acids, Eicosapentaenoic / Docosahexaenoic Acid (EPO/DHA), powerful but also necessary antioxidants for the human body, after observational studies as well as randomized studies seem to have a beneficial effect in the direction of the prevention of CVD with pleiotropic mechanisms. Lignin, a polymer of plant origin that is considered a dietary fiber, has a developed porous structure and can retain exogenous and endogenous toxins, and pathogenic microorganisms. Lactulose considered a prebiotic provides a selective substrate for the metabolism of saccharolytic bacteria with bifidogenic activity and multiple benefits to the host's gut health. Coronary artery bypass grafting (CABG) is an established surgical intervention and treatment of symptoms of myocardial ischemia that improves patient survival Optimal Medical Therapy (OMT) after coronary arterial bypass grafting (CABG) as described in current clinical practice could be made even better by the addition of these beneficial food supplements. A randomized controlled trial is proposed in an intervention group of 54 post-CABG patients who will be given daily orally in addition to the usual medication, 1000 mg Vitamin C, 840 mg EPO/DHA, 2130 mg Lignin \& 720 mg Lactulose and a control group of 54 patients (Control Group) in which only usual medication will be administered. The intervention will take place from the 15th postoperative day when CAGB patients are discharged and lasts for 2.5 months (10 weeks) postoperatively. The data will be collected on the 15th, 80-90th postop day in 6 months and 12 months postop and then the statistical analysis of the data will be performed. Considering the number of CABG surgeries performed electively in our clinic, this study is expected to be completed in approximately 2-3 years from the day of initiation. The expected knowledge through the expected results such as these will emerge from this study is the potentially beneficial effect of our food supplements administration (intervention), i.e. Vitamin C, EPO/DHA, Lignin \& Lactulose, on the postoperative course of our patients. Some degree of improvement in the well-being and clinical picture of our patients postoperatively is expected, which will be thoroughly investigated in each phase of the study.

Combination of IV Ascorbic Acid and Adebrelimab in Metastatic Colorectal Cancer

Previous preclinical study has shown that high levels of ascorbic acid (AA) possesses the ability to kill human colorectal cancer cells and high expression of GLUT3 will augment the efficacy of AA. To date, no previous studies have investigated the combination of therapeutic role of AA and PD-L1 antibody in metastatic colorectal cancer with high expression of GLUT3. This protocol is a randomized controlled study of AA infusions combined with Adebrelimab and FOLFOX +/- bevacizumab versus treatment with FOLFOX +/- bevacizumab alone in metastatic colorectal cancer patients with high expression of GLUT3.