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Vitamin D Deficiency clinical trials

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NCT ID: NCT04525820 Completed - Covid19 Clinical Trials

High Dose Vitamin-D Substitution in Patients With COVID-19: a Randomized Controlled, Multi Center Study

VitCov
Start date: December 15, 2020
Phase: N/A
Study type: Interventional

The world is currently facing a pandemic with the coronavirus (SARS-CoV-2) which leads to the disease of COVID-19. Risk factors for a poor outcome of COVID-19 have so far been identified as older age and co-morbidity including chronic respiratory conditions such as chronic obstructive pulmonary disease (COPD) and current smoking status. Previous studies found, that vitamin D deficiency is more prevalent among patients with these risk factors. There are observational studies reporting independent associations between low serum concentrations of 25-hydroxyvitamin D (the major circulating vitamin D metabolite) and susceptibility to acute respiratory tract infection. Vitamin D substitution in patients with COVID-19 who show a vitamin D deficiency should therefore be investigated for efficacy and safety. The study is designed as a randomized, placebo-controlled, double blind study. The objective of the study is to test the hypothesis that patients with vitamin D deficiency suffering from COVID-19 treated under standardized conditions in hospital will recover faster when additionally treated with a single high dose of vitamin D compared to standard treatment only.

NCT ID: NCT04482673 Active, not recruiting - COVID-19 Clinical Trials

Vitamin D Supplementation in the Prevention and Mitigation of COVID-19 Infection

VitD-COVID19
Start date: July 31, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate how useful vitamin D supplementation is in reducing the severity of COVID-19 symptoms and the body's inflammatory and infection-fighting response to COVID-19. Individuals ≥50 years of age and older who are tested for COVID-19 and negative will be randomized (like flipping a coin) to either daily high dose vitamin D supplementation (6000 IU vitamin D3/day) vs. standard of care. Those individuals ≥50 years of age or older who test positive for COVID-19 at baseline will be randomized to bolus vitamin D (20,000 IU/day for 3 days) followed by high dose (6000 IU vitamin D/day) vs. standard of care for 12 months. All participants will receive a multivitamin containing vitamin D.

NCT ID: NCT04482465 Completed - Clinical trials for Vitamin D Deficiency

Omega 3 and Vitamin D Dosage in a Population With Moderate to High Risk of AMD

OVID-AMD
Start date: April 20, 2017
Phase: N/A
Study type: Interventional

Objectives: The investigators conducted a prospective study in Belgium with the objective to determine the proportion of subjects identified at moderate-to-high risk for AMD, based on the STARS® questionnaire, in need of nutritional supplementation by assessing their vitamin D, zinc oxide and fatty acid profile status. Methods: This multicentre epidemiological intervention pilot study involved 50 Belgian subjects with no AMD or early AMD, aged over 55, at moderate-to-high risk for AMD based on a simplified AMD risk assessment scale (STARS®) score ≥ 10, not taking vitamin D or trace nutrient containing supplements. Outcome data was collected during a one-time subject interview comprising of clinical eye examinations (typically visual acuity), the STARS® questionnaire, visual acuity assessment, an OCT scan on the macula, and fundus photography. Blood samples were collected from the patients and serum analysis was performed to determine the levels of omega-6 to omega-3 ratio, EPA and DHA, zinc and cupric oxide, and vitamin D, recognised as key nutrients involved in AMD pathophysiology.

NCT ID: NCT04476680 Recruiting - Covid19 Clinical Trials

Influence of Military Preventive Policy for reCruit Training on COVID-19 Seroconversion

IMPACTCOVID
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

This study is intended to address the association between vitamin D status and seroconversion to SARS-CoV-2 in healthy young adults. The primary aim of the study is to determine the rates of 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population with a wide spread of vitamin D concentrations. The secondary aims of this study are to explore: 1. Any effect of vitamin D status on symptomatic illness. 2. The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults. 3. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time. 4. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method 5. The effect (if any) of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.

NCT ID: NCT04476511 Completed - Clinical trials for Vitamin D Deficiency

The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules

Start date: September 5, 2018
Phase: Phase 3
Study type: Interventional

Treatment: A: Slower Loading Group (SLD): 30.000 IU cholecalciferol once weekly for ten weeks, followed by 30.000 IU cholecalciferol every two weeks for four weeks. B: Moderate Loading Dose group (MLD): 30.000 IU cholecalciferol twice weekly for five weeks, followed by 30.000 IU cholecalciferol every two weeks for four weeks. Every patients will receive calcium-citrate supplementation if average daily calcium intake does not reach the recommended daily amount. Setting: two-arms, controlled, randomised, comparative open-label, multicentric clinical trial aimed to assess the comparative efficacy on 25(OH)D elevation and on safety of the two loading dose schedules of 30.000 IU Vitamin D3 oral tablets (administered as "Moderate Loading Dose"or "Slower Loading Dose") combined with an follow-up maintenance period of biweekly administration. The comparative assessment is based on the elevation of 25(OH)D levels due to treatment efficacy from baseline and by the end of the maintenance (biweekly 30.000 IU) period for each treatment groups, and also the ratio of patients in target range (30-50 ng/ml) in order to evaluate the most beneficial "loading dose" schedule. Upon the serum 25(OH)D levels are exceeded the 55ng/ml limits by the end of the loading period the trial subjects should continue with the standard maintenance dose of vitamin D3 for the remaining four weeks of the study. The evaluation of the comparative safety will be done also by controlling the serum and the urinary calcium levels and the registration of adverse drug reaction. The primary objective is to assess the efficacy of the orally administered loading dose schedules of vitamin D3 in deficient patients. Efficacy is measured as the elevation of 25(OH)D levels compared to baseline. Rationale: Oral vitamin D3 is the treatment of choice in vitamin D deficiency. The UK NOS guideline recommended where rapid correction of vitamin D deficiency is required, such as in patients with symptomatic disease or about to start treatment with a potent antiresorptive agent, the recommended treatment regimen is based on fixed loading doses followed by regular maintenance therapy. The loading dose regimen to provide a total of approximately 300,000 IU vitamin D, given either as separate weekly or daily doses over 6 to 10 weeks followed by a maintenance therapy comprising vitamin D in doses equivalent to 800-2000 IU daily in general or up to 4,000 IU daily), given either daily or intermittently at higher doses. (NOS guidelines 2014). Recent research on vitamin D and the widening range of therapeutic applications available for cholecalciferol, which can be classified as both a vitamin and a pro-hormone. Additionally, it was now realized that the Food and Nutrition Board's previously defined Upper Limit (UL) for safe intake at 2,000 IU/day was set far too low and that the physiologic requirement for vitamin D in adults may be as high as 5,000 IU/day, which is less than half of the >10,000 IU that can be produced endogenously with full-body sun exposure. In a recent study showed that the safety of doses over 2000 IU/day-4000 IU/day for 3 months resulting in a ~360,000 UI cumulative dose. According to the study results, for the majority of the patients the 4000 IU/day (360,000 UI cumulative dose) was needed to achieve a 25(OH)D serum concentration above 75nmol/L (30 ng/mL), which is otherwise set as the target value by Endocrine Society Clinical Practice Guideline (Holick 2011b). Another study (Verussio et al 2014) cited shows the safety and efficacy of 50.000 IU/week for 8 weeks (400,000 UI cumulative dose for 8 weeks), followed by 25,000 IU twice a month which was more effective in raising the 25(OH)D level to the target range (of >30 ng/L) than 25,000 IU twice a month (50,000 IU/ month). In the latter group only 40% of the patients reached the target 25(OH)D levels at 6 months, compared to the 72% in the first group. The study supports efficacy of dosing and safety of the treatment of vitamin D deficiency a 50,000 IU /week loading dose scheme with a 8 weeks cumulative dose of >400,000 UI.

NCT ID: NCT04469257 Completed - Clinical trials for Vitamin D Deficiency

SUN LIGHT EXPOSURE AND VITAMIN D LEVEL IN NURSING HOME

Start date: June 27, 2018
Phase: N/A
Study type: Interventional

Objective: The aim of the present study was to determine the effect of nursing interventions and sunlight exposure to reach optimum vitamin D levels by individuals living in nursing homes on vitamin D levels. Material Method: In the first stage of this two-stage randomized-controlled experimental study with pretest-posttest design conducted in June - August 2018 period in the nursing home in Central Town of Tokat Province, the questionnaire prepared by the researcher, standardized mini mental test, Fitzpatrick skin typing questionnaire and Katz Index of activities of daily living were applied. Intervention (n=20) and control (n=20) groups were established with individuals using simple random method according to age, gender, skin type and vitamin D level. In the second stage, 30-35% of the body surface area of individuals in the intervention group was exposed to sunlight five days a week in July. For the participants in the control group, sunbathing was not offered. 25(OH)D, calcium, parathormone, phosphorus, alkaline phosphatase and albumin levels of all individuals were measured in blood samples taken at the beginning and end of the study. Two-way mixed ANOVA, Mann-Whitney U test, Wilcoxon signed rank test and Chi-square tests were used to evaluate the data.

NCT ID: NCT04461665 Completed - Clinical trials for Vitamin D Deficiency

Effects of Vitamin D Supplementation on Immune Function in Infants

Start date: August 18, 2015
Phase: N/A
Study type: Interventional

Current study shows that vitamin D deficiency might affect human's immune function. Although breast milk is the best food of infants, however the vitamin D content in breast milk is low. Thus, breastfeeding infants are at high risk of vitamin D deficiency.Children's development and health are always the most important issues for parents. However, high prevalence of allergy in infants in Taiwan were not only with environmental factor which may also relate to their nutritional status. The aim of this study was to enroll breastfeeding infant at age of 4 month, and provide vitamin D supplement 10 μg daily until 6 month, to discuss the effects of vitamin D supplementation on immune function in infants.

NCT ID: NCT04450199 Completed - Clinical trials for Vitamin D Deficiency

Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery?

Start date: July 24, 2020
Phase: Early Phase 1
Study type: Interventional

To assess if vitamin D status in the elective foot and ankle fusion population affects fusion healing categorically (fused vs. un-fused).

NCT ID: NCT04412694 Recruiting - Postoperative Pain Clinical Trials

The Effect of Preoperative Oral Dexamethasone Supplementation on the Outcome of Thyroidectomised Patients.

Dexa
Start date: July 1, 2020
Phase: Phase 4
Study type: Interventional

Glucocorticoids are well known for their analgesic, anti-inflammatory, immunomodulatory and anti-emetic effects. Recovery time after thyroid surgery may depend on several factors, such as postoperative pain, nausea and vomiting, postoperative sore throat, voice disorders and symptomatic hypocalcaemia (low serum calcium level). However, there is little information in the literature about the preventive use of glucocorticosteroids in patients undergoing thyroid surgery. The aim of the study is to evaluate the clinical impact of preoperative oral dexamethasone supplementation on the surgical outcome in patients with multinodular goiter undergoing total thyroidectomy. Patients will be assigned to the supplementation group and the placebo group. In the supplementation group 8mg of dexamethasone will be administered orally one hour before surgery. In the postoperative period, the frequency and intensity of pain, nausea, vomiting, sore throat and hoarseness will be assessed. The incidence of symptoms of hypocalcaemia will also be evaluted. Preoperative and postoperative levels of vitamin D, cytokines, acute phase proteins and substances related to calcium metabolism will be measured in the blood. Cytokines levels in drainage fluid will also be assessed. The main hypothesis of the study is that in patients with supplementation postoperative discomfort and decrease in serum calcium and parathormone level and hypocalcemic symptoms will be less severe and the levels of proinflammatory substances will be decreased.

NCT ID: NCT04407572 Completed - Clinical trials for Vitamin D Deficiency

Evaluation of the Relationship Between Zinc Vitamin D and b12 Levels in the Covid-19 Positive Pregnant Women

Start date: April 20, 2020
Phase:
Study type: Observational

Zinc d vitamin and b12 serum levels in covid-19 positive pregnants will be compared in terms of patients' responses to computed tomography and treatment.