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Avitaminosis clinical trials

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NCT ID: NCT03381378 Completed - Children Clinical Trials

Vitamin D and Hand Grip Strength at 5 Years in Odense Child Cohort

VITHGS
Start date: January 4, 2016
Phase: N/A
Study type: Observational

This study will encompass an analysis of an eventual association between vitamin D status (maternal during pregnancy, at birth or at 5 years) and hand grip strength at 5 years in children from Odense Child Cohort. Odense Child Cohort is a large-scale, prospective, population-based, follow-up study. Mothers and their children born from January 2010 to December 2012 and resident in the Municipality of Odense, Denmark, are followed from early pregnancy up to adulthood. Data is obtained from questionnaires and medical records and venous blood samples were drawn and stored at a biological bank. Low muscle strength in children has been linked to adiposity, cardiovascular disease and metabolic risk factors and low muscle strength in adolescence has been shown to be a risk factor of early adulthood mortality. There are not many studies on muscle strength in small children. There is some evidence of vitamin D concentrations in the blood having a positive correlation to upper body muscle strength in adolescent girls. Hypovitaminosis D defined as serum 25-hydroxyvitamin D <50nmol/L was evident in 27,8% of the pregnant women and 47,7% of the new-born children in Odense Child Cohort. Animal studies have shown an effect of vitamin D on regulation of muscle function and development. Studies on humans adults have shown that vitamin D deficiency can lead to myopathy. Myopathy in children as a result of hypovitaminosis D is not well-studied. Given the high prevalence of hypovitaminosis D, mild or severe vitamin D-associated myopathy may be prevalent in preschool children. The objectives of this study are 1) to create reference values and determine predictors of hand grip strength at five years, 2) to analyze the associations between vitamin D at different time points and hand grip strength at 5 years.

NCT ID: NCT03369379 Completed - Fibromyalgia Clinical Trials

Valuation of Efficacy and Safety of Vitamin D3 Use in 80 Women Diagnosed With Fibromyalgia. Using FIQ Score and VAS.

Start date: May 31, 2017
Phase: Phase 4
Study type: Interventional

Fibromyalgia is a disease that significantly decreases the quality of life of people who suffer from it, has great repercussions at the socio-economic level due to the incapacity it produces. It is characterized by generalized pain, fatigue, sleep disorders, psychological stress and mental alterations, besides presenting painful points in different parts of the body to physical examination. Having few effective treatments is necessary to explore new options in their management to improve the general conditions of the patient. Previous studies have shown that patients with fibromyalgia have had low levels of vitamin D in the blood, a favorable response from post-vitamin D supplementation has been seen. This vitamin has been associated with pain pathways and with increased The perception of the same when it is in smaller amount. We will select patients with Fibromyalgia diagnosis from the external consultation of Rheumatology of the University Hospital "Dr. José Eleuterio González "of the UANL, over 18 years old who have not been previously supplemented with vitamin D, will initially be measured in blood of vitamin D, in addition to calcium as a safety measure, we will have a group that will only receive placebo and Another that will be supplemented with 50 thousand units weekly for 12 weeks, we will apply a questionnaire that measures pain scale and another one that measures the impact of the disease in the daily life of the patient, this will be done in a beginning and at the end of the 12 weeks .

NCT ID: NCT03360435 Completed - Clinical trials for Bariatric Surgery Candidate

Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients

Start date: December 15, 2017
Phase:
Study type: Observational

Patients undergoing bariatric surgery often develop new vitamin and/or mineral deficiencies or exacerbate prior deficiencies after surgery. Several bariatric supplement products exist including oral tablets and transdermal patches. The purpose of this study is to observe the concentrations of serum micronutrients and determine how many deficiencies develop in patients who use a transdermal patch.

NCT ID: NCT03272126 Completed - Hypovitaminosis D Clinical Trials

Importance of Dosing Regimen for the Effect of Vitamin D Supplementation

Start date: December 1, 2017
Phase: Phase 3
Study type: Interventional

Vitamin D is a hormone with effects not only on the skeleton, but on most tissues in the body. Lack of vitamin D is associated with cardio-vascular disease (CVD), type 2 diabetes, cancer, infectious and immunological diseases, as well as risk factors for these diseases. However, intervention studies with vitamin D have been inconclusive regarding diseases and risk factors. This could be due to inclusion of subjects already vitamin D sufficient, and short and underpowered studies. In addition, there are indications that the dosing regimens may be important, so that daily doses with vitamin D are more efficient than intermittent doses, which so far have been generally used. This could be related to the concentration of circulating and thereby intracellular vitamin D concentrations, which probably is dependent on daily vitamin D doses. This will be tested in the present study where 60 subjects will be randomized to vitamin D 160 000 once, vitamin D 4000 IU/day, or placebo for four weeks. The primary endpoints will be effects on serum hepcidin and plasma cathelicidin after 4 weeks, with effects on serum PTH, RNA expression and microRNA in peripheral blood, telomerase activity in peripheral blood mononuclear cells and the ration between serum 1,25(OH)2D and 24,25(OH)2D as secondary endpoints.

NCT ID: NCT03272022 Completed - Deficiency Vitamins Clinical Trials

Micronutrient Status During Pregnancy

Start date: December 14, 2011
Phase:
Study type: Observational

An adequate micronutrient status during fetal life and infancy is important for optimal development. Dietary practices during pregnancy, lactation and infancy vary among populations and there is today no clear agreement on what constitutes the best diet, including micronutrient supplementation, during this period. There is consequently no clear agreement on what constitutes an optimal biochemical micronutrient status in mothers and infants. Due to substantial physiological changes in plasma volume, hormones, transport proteins and organ function during these periods, the ordinary reference levels or cut off levels used for biochemical assessment of micronutrient status are unsuited to these groups of patients. The objective of the study is to establish cut off levels for important vitamins and trace elements during pregnancy, lactation and infancy in order to ensure an optimal infant neurodevelopment and to study how micronutrient status influence the immunosystem.

NCT ID: NCT02890823 Completed - Epilepsy Clinical Trials

Effect of Three Different Doses of Oral Cholecalciferol on 25-Hydroxyvitamin D Changes Among Epilepsy Patients With Hypovitaminosis D

Start date: July 2015
Phase: Phase 4
Study type: Interventional

To characterize the effect of three different doses of vitamin D3 supplementation on serum 25-hydroxyvitamin D (25(OH)D) changes in epilepsy patients receiving enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs), and to determine the prevalence of and risk factors for hypovitaminosis D among Thai patients with epilepsy.

NCT ID: NCT02881957 Completed - Stroke Clinical Trials

Hypovitaminosis D in Neurocritical Patients

Start date: October 10, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Vitamin D has been shown to impact prognosis in a variety of retrospective and randomized clinical trials within an intensive care unit (ICU) environment. Despite these findings, there have been no studies examining the impact of hypovitaminosis D in specialized neurocritical care units (NCCU). Given the often significant differences in the management of patients in NCCU and more generalized intensive care units there is a need for further inquiries into the impact of low vitamin D levels in this specific environment. This study proposes a randomized, double-blinded, placebo-controlled, single center evaluation of vitamin D supplementation in the emergent NCCU patient population. The primary outcome will involve length-of-stay for emergent neurocritical care patients. Various secondary outcomes, including in-hospital mortality, ICU length-of-stay, Glasgow Outcome Score on discharge, complications and quality-of-life metrics. Patients will be followed for 6 months post-discharge.

NCT ID: NCT02847962 Completed - Clinical trials for Anemia, Iron-Deficiency

Newly Formulated, Extruded Fortified-blended Foods for Food Aid: the MFFAPP Tanzania Efficacy Study

Start date: February 2016
Phase: N/A
Study type: Interventional

Corn-soy vitamin and mineral fortified blended foods (FBFs) are primarily used for food aid, although sorghum and cowpea may be suitable alternative FBF commodities. The objective of the Micronutrient Fortified Food Aid Pilot Project (MFFAPP) Tanzania Efficacy Study is to determine whether newly formulated, extruded sorghum- and cowpea-based FBFs have equal, or better, nutritive value and acceptance compared to a traditional corn-soy blend. The effectiveness of each blend will be determined in an efficacy study of Tanzanian children under the age of 5 that are deficient, or at risk for deficiency, in iron and vitamin A.

NCT ID: NCT02822651 Completed - Vitamin D Status Clinical Trials

Hypovitaminosis D Prediction Score

SCOPYD
Start date: September 19, 2016
Phase: N/A
Study type: Interventional

Vitamin D has effects on many tissues, and hypovitaminosis D is frequent. In a French survey conducted among 1587 adults, vitamin D insufficiency (<30ng/ml) has been reported in 80% of subjects, including 43% with moderate deficiency (<20ng/ml) and 5% with severe deficiency (<10ng/ml). Because of the possible consequences of hypovitaminosis D (osteomalacia in adults…), the number of vitamin D determination has increased ten-fold since 2005 in France, reaching 4.5 million € in 2011, and with it the costs for health insurance. However, there is currently no consensus on the strategy for detection, diagnosis and treatment of hypovitaminosis D. We propose to develop a predictive clinical score of hypovitaminosis D based on the accurate assessment of solar exposure, vitamin D intakes and hypovitaminosis D risk factors collected through a self-administered questionnaire.

NCT ID: NCT02802449 Completed - Hypovitaminosis D Clinical Trials

To Study the Nutri-Genomic Response of Vit-D Supplementation in African-Americans

Start date: September 2013
Phase: N/A
Study type: Interventional

Three hundred thirty (330) overweight, pre-hypertensive/controlled hypertensive, African-American participants will be enrolled in a 8 week study to assess the effect of two administrations of Vitamin D3 on Vitamin D serum responsiveness as a function of clinical, biologic and genetic factors. The investigators anticipate that at least 300 participants will complete this study. Written, signed and dated informed consent to participate in the study will be given by the participant or a legally acceptable representative, in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related activities/procedures. The original signed and dated consent will be kept in the subject's research file and a copy given to the subject. A copy will also be placed in their medical record.