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Vitamin D Deficiency clinical trials

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NCT ID: NCT06366776 Not yet recruiting - Clinical trials for Vitamin D Deficiency

Emulated Study of Vitamin D Correction vs Non-Correction

Start date: April 2024
Phase:
Study type: Observational

- This is a single-site retrospective electronic chart review of Cooper Health System Inpatients and Outpatients from 2008 through 2023 aged eighteen years or older. This review is designed as an emulation of a randomized clinical trial with a nonrandomized database. - The primary objectives are to compare healthcare costs and healthcare utilization between subjects who have corrected low vitamin D levels and those without corrected low vitamin D levels.

NCT ID: NCT06258850 Not yet recruiting - Clinical trials for Vitamin d Deficiency

REstoration of VItamin D in Pulmonary Arterial Hypertension

REVIDAH
Start date: July 1, 2024
Phase: Phase 4
Study type: Interventional

Background. Pulmonary arterial hypertension (PAH) is a heterogeneous pathophysiological condition characterized by progressive pulmonary vascular narrowing that ultimately results in right-sided heart failure and eventually death or lung transplantation. The effectiveness of current pharmacological treatments is suboptimal and a large proportion of patients still had events or died despite receiving combination therapy. Vitamin D deficiency has been found to be much more frequent in PAH patients than in the general population or even compared to patients with other severe cardiovascular diseases. Moreover, vitamin D deficiency has a negative prognostic impact in PAH. Animal studies support that vitamin D deficiency worsens PAH. Hypothesis. In patients with PAH and vitamin D deficiency, restoration of vitamin D status with calcifediol improves their symptomatology and prognosis. Design: Multicenter clinical trial with the participation of 9 hospitals, placebo-controlled, randomized (1:1 ratio), in two parallel groups (without crossover), triple blind, and add-on on existing treatments (add-on). It will include at least 102 subjects (51 in the calcifediol group and 51 in the placebo group) followed for 24 weeks of treatment. Inclusion criteria: Patients of both sexes (18-75 years) with hemodynamic diagnosis of PAH and severe vitamin D deficiency (25-OHvitD <= 12 ng/ml) and without previous diagnosis of osteoporosis or osteomalacia. Treatments: 1) Calcifediol Hydroferol® 0.266 mg once every 10 days for the first 12 weeks and once every two weeks for the following 12 weeks. 2) Placebo. Main objective: A composite endpoint of clinical improvement without clinical worsening at week 24. Expected outcome: Restoration of vitamin D status is an unexpensive measure, very easily implantable and that could improve the evolution of the disease as well as other aspects such as bone or immune health and that has few side effects.

NCT ID: NCT06199102 Not yet recruiting - Clinical trials for Vitamin D Deficiency

The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.

HIDVID
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

The aim of this study will be to assess the effectiveness of monitored vit D supplementation in a population of preterm infants and to identify whether the proper vit D supplementation in preterm infants can reduce the incidence of neonatal sepsis and incidence of metabolic bone disease.

NCT ID: NCT06176157 Not yet recruiting - Clinical trials for Vitamin D Deficiency

Vitamin D Supplementation in Pediatrics. Oral or Parenteral! D2 or D3

Start date: December 2023
Phase: Phase 4
Study type: Interventional

A study will be performed on Vitamin D deficient/ insufficient Egyptian children to compare the efficacy of oral and parenteral forms of Ergocalciferol and cholecalciferol in raising serum 25(OH) D levels in these subjects

NCT ID: NCT06111066 Not yet recruiting - Clinical trials for Vitamin d Deficiency

Vitamin D Levels in Neonatal Umbilical Cord Blood: Factors and Prognostic Analysis

Start date: January 1, 2024
Phase:
Study type: Observational

This study is a retrospective-prospective cohort study that investigates the factors influencing neonatal umbilical cord blood 25(OH)D levels, and the impact of exposure to low intrauterine 25(OH)D levels on neonatal prognosis. Newborns born in Sun Yat-sen Memorial Hospital of Sun Yat-sen University from August 2023 to August 2024 were selected. 2ml of umbilical cord blood was collected to test serum 25(OH)D levels. Based on the umbilical cord blood 25(OH)D levels, newborns were divided into three groups: vitamin D deficiency (<30nmol/L), insufficiency (30~50nmol/L), and sufficiency (>50~250nmol/L). Factors influencing neonatal vitamin D levels at birth were investigated by reviewing medical records, questionnaire collection, phone interviews, etc., collecting data on basic neonatal information, maternal information, complications during pregnancy, prenatal biochemical test results, medication history during pregnancy, lifestyle habits during pregnancy, and vitamin D supplementation status. Phone follow-ups on the health of the newborns during their hospital stay and at 1 month and 2 months after discharge were conducted to investigate the impact of exposure to low intrauterine 25(OH)D levels on neonatal prognosis, providing a theoretical basis for early intervention in high-risk pregnant women and early identification of high-risk groups with vitamin D deficiency or insufficiency among newborns. Miscarriages prevention is a major feature of our hospital's obstetrics department. Many pregnant women who are hospitalized and give birth at our hospital have a history of fetus protection. Choosing pregnant women and newborns from our hospital's obstetrics department as research subjects is conducive to exploring the impact of specific diseases and medication histories on neonatal vitamin D deficiency, which is an innovative aspect of this study.

NCT ID: NCT05863949 Not yet recruiting - Clinical trials for Vitamin D Deficiency

Clinical Trial of Vit D and Calcium for Recurrent BPPV

Start date: July 2023
Phase: N/A
Study type: Interventional

Randomized double blind placebo controlled trial of vitamin D supplements, with or without calcium supplementation, versus placebo in reduction of recurrences in BPPV.

NCT ID: NCT05852496 Not yet recruiting - Clinical trials for Vitamin D Deficiency

Vit D and Peripheral Neuropathy in Taxane Naive Patients

Start date: July 1, 2023
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy of vit D supplement in cancer patients which receive taxane drugs with vit D deficiency and complaining from Peripheral neuropathy

NCT ID: NCT05702970 Not yet recruiting - Heart Failure Clinical Trials

Beneficial Effects of Vitamin D Combined With Oral Iron Supplementation in Patients With Chronic Heart Failure and Iron Deficiency

VICTORID-HF
Start date: January 15, 2024
Phase: Phase 4
Study type: Interventional

The goal of this randomized, controlled, open-label, interventional study is to evaluate whether, in patients with heart failure (HF) and iron deficiency (ID), the administration of vitamin D in combination with sucrosomial iron is as effective as intravenous ferric carboxymaltose in improving symptoms of HF. The main hypothesis which the study aims to test is the non-inferiority of sucrosomial iron (± vitamin D) compared with FCM treatment, after 24 weeks. Primary endpoint: the performance of the Six-Minute Walking Test, comparing the mean difference from baseline of the distance walked by patients in meters. Participants will be evaluated in outpatient scheduled visits at 6, 12 and 24 weeks, performing blood tests, clinical evaluation, instrumental investigations and recording any adverse events, cardiovascular events, re-hospitalizations and fractures. The study will involve randomization into 3 groups with a 1:1:1 ratio: 1. Control group [standard of care]: administration of FCM (Ferinject®) with a dose between 500 and 2000 mg (depending on body weight and hemoglobin values), to be administered in 1 or 2 doses (time 0 ± 6 weeks) with possible additional administration of 500 mg at week 12 in case of persistent ID. 2. Sucrosomial iron group: administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once a day for 24 weeks. 3. Sucrosomial iron and vitamin D group: administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once daily + vitamin D3 (100,000 IU load at time 0, then 2,000 IU daily) for 24 weeks

NCT ID: NCT05650151 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Peri-operative Vitamin D Therapy for Hepatectomy

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The goal of this double-blind, randomized controlled trial is to test the effect of short-term and high-dose vitamin D therapy in patients undergoing hepatectomy for hepatocellular carcinoma.

NCT ID: NCT05568836 Not yet recruiting - Clinical trials for Vitamin D Deficiency

Relationship Between Serum Vitamin D and Outcomes of Liver Transplantation in Cirrhotic Patients Undergoing Liver Transplantation and Effects of Vitamin D Supplementation in Post-transplant Period

Start date: November 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The study population is patients with liver cirrhosis undergoing liver transplantation; In this study, the sample will be selected from cirrhosis patients undergoing liver transplantation in Taleghani (Tehran), Imam Khomeini (Tehran) and Abu Ali Sina hospitals(Shiraz). This study uses the recorded information of patients with cirrhosis who have undergone liver transplantation so far and have inclusion criteria and no exclusion criteria. First, we extract demographic and clinical and pathophysiological information of patients, including age, sex, BMI, cause of cirrhosis, medical status at the time of liver transplantation, history of abdominal surgery, portal vein thrombosis, and waiting time for liver transplantation. In the next step, we examine the serum level of vitamin D in different age and sex groups and determine the prevalence of vitamin D deficiency for each group. It should be noted that in this study, the serum level of 25-hydroxy vitamin D below 20 ng/mL will be considered an insufficient level. In the next step, in patients 12 years of age and older, according to serum bilirubin, serum creatinine, serum sodium and INR, we calculate the MELD-Na score and evaluate it with the serum level of vitamin D or 25-hydroxy vitamin D. We also use PELD scores in patients younger than 12 years of age, which consist of age, serum albumin, total bilirubin, INR, and stunted growth. Follow-up will be done by calling the patients and recruitment every 3 month. ACR or acute cell rejection is usually suspected after elevated liver enzymes (serum aminotransferases, alkaline phosphatase, gamma glutamyl transpeptidase) or bilirubin (30). The incidence of ACR and Overall survival (OS) will be considered as the end point of the first phase of the study, and finally the incidence of 25-hydroxy vitamin D before transplantation with MELD-Na or PELD score will be examined. ACR and OS, we deal with statistical tests. In the second phase of the study, which is a clinical trial, 50 sample patients with vitamin D deficiency will be selected from Taleghani Hospital; After transplanting, we will inject 300,000 units of vit D IM and compare their ACR and OS levels with those who have been deficient in vitamin D but whose vitamin D status has not improved. It is worth mentioning that in the second phase of the study, patients will be followed up to 3 months after liver transplantation.