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Vitamin D Deficiency clinical trials

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NCT ID: NCT03162406 Recruiting - Clinical trials for Vitamin D Deficiency

Effects of Vitamin D Supplementation During a Non-surgical Treatment of Generalized Chronic Periodontitis

Protocol01
Start date: May 18, 2017
Phase: N/A
Study type: Interventional

The subjects participating in the trial will be randomly allocated to either the group receiving the treatment under investigation (scaling and root planning (SRP) accompanied by administration of vitamin D) or to a group receiving standard treatment (SRP in conjunction with placebo) as the control. Random assignment of intervention will be done after subjects have been assessed for eligibility and recruited, but before the intervention to be studied begins. After randomization, the two groups of subjects will be followed in exactly the same way and the only differences between them will be the vitamin D/placebo that they will receive.

NCT ID: NCT02803476 Recruiting - Insulin Resistance Clinical Trials

Is There Association Between Vitamin D Levels And Insulin Resistance In Polycystic Ovary Syndrome?

Start date: March 2016
Phase: N/A
Study type: Observational

The primary aim of the current study is to clarify whether serum vitamin D levels [25(OH)D3] have a temporal association with insulin resistance and/or insulin sensitivity in PCOS women versus healthy ones. To achieve this aim, the investigators will conduct a prospective observational study involving obese and lean PCOS women in comparison to obese and lean healthy subjects living in Cairo, Egypt.

NCT ID: NCT02735200 Recruiting - Clinical trials for Vitamin D Deficiency

Topical Delivery of Vitamin D3 as Vitamin D Supplementation

Start date: April 2016
Phase: Phase 1/Phase 2
Study type: Interventional

After obtaining the approval from the IRB of University of Dammam and informed consent from 550 healthy patients, with vitamin D deficiency and vitamin D insufficiency and deficiency were recruited. Age, weight and height will be taken, a detailed history, meticulous clinical examination was performed to rule out any diseases and complete blood picture, serum calcium, phosphorous, alkaline phosphatase, Parathormone and 25 Hydroxy-vitamin D (25OHD) will be done. 25-Hydroxy Vitamin D3 was measured in house by chemiluminescence immunoassay (CLIA) and ≥30ng/mL was taken as normal, 21-29ng/mL as insufficiency and ≤20 ng/mL as deficiency. The participants were divided into two groups of 350 in study arm and 200 in control arm. All participants were instructed not to change their dietary habits and life style till the study was over. The study group of women were instructed to apply to apply Top-D (Proniosomal Delivered- Vitamin D3) 1 gram containing 5000 IU of vitamin D3. The second group used 1 gram of Aloe vera gel. The participants had no knowledge to which group they belong. A second blood sample was taken at the end of 4 months and the data was entered in the data base and analyzed using SPSS Inc version 19.

NCT ID: NCT02389179 Recruiting - Clinical trials for Vitamin D Deficiency

Determination of Vitamin D Dose to Maintain Sufficiency Amongst Indian and Malay Women in the Tropics

Start date: August 2014
Phase: Phase 4
Study type: Interventional

Much research on vitamin D status has focused on seasonal variations in serum 25(OH)D levels in populations living at high altitudes and those of light-skinned Caucasian extraction, with little work done in multi ethnic populations living closer to the equator with regards to Vitamin d supplementation, prevalence, predictors and associations of hypovitaminosis D - the assumption, perhaps being vitamin D deficiency is unlikely in locations of plentiful sunshine. There is a dearth of studies on Vitamin D status in a group of subjects at especially high risk of falls/fractures i.e. post-menopausal women with osteoporosis living in South-East Asia. It is possible that differences in geography and ethnicity/culture amongst women with post menopausal osteoporosis (PMO) in Malaysia may necessitate supplemental Vitamin D doses that differ from those prescribed to North American Caucasians. There is no unified consensus on the dose of Vitamin D supplementation. Neither is there agreement on definitions of sufficiency with some researchers targeting levels of serum 25(OH)D of >20ng/ml and others aiming for levels above 30ng/ml. The Institute of Medicine (IOM) 2010 guidelines, aiming for a lower serum 25(OH)D target of 20ng/ml, advocates maintenance doses of 600 IU/day in Postmenopausal women aged 51-70 and 800 IU/day for those aged >70 years. On contrary, the Endocrine Society 2011 guidelines state that maintenance doses up to 1500-2000 IU/day may be required to attain a higher optimal target of >30ng/ml. On addition, the 2014 National Osteoporosis Foundation Guidelines recommended that the Vitamin D level should be brought up to approximately 30ng/ml, and to maintain at this level taking into account those with limited sun exposure, obese and dark skin individuals, the daily requirement ranges from 800-2000 IU/day. The investigators therefore designed a prospective randomized controlled trial comparing efficacy and safety of a low (900 IU/day) and high (1800IU/day and 3300IU/day) maintenance dose of Cholecalciferol (Vitamin D3) amongst community dwelling Indian and Malay with PMO living in Kuala Lumpur, Malaysia. Hypothesis of the study is despite abundant exposure to sunlight, which is the main Vitamin D supplier, those who dress conservatively and individuals with darker skin may require a higher dose of Vitamin D to maintain sufficiency (>30ng/ml).

NCT ID: NCT02351284 Recruiting - Hypovitaminosis D Clinical Trials

Impact of Hypovitaminosis D on Bone Disease in HIV Infected Patients

PuraVIHta
Start date: January 12, 2019
Phase:
Study type: Observational [Patient Registry]

To determine the prevalence of hypovitaminosis D in HIV infected patients, and the consequences on secondary hyperparathyroidism, and bone mineral density (BMD). Also, to establish the improvement in vitamin D status, parathyroid hormone (PTH) and BMD, in case of receiving vitamin D supplementation, during a follow up period of at least 1 year.

NCT ID: NCT02243800 Recruiting - Clinical trials for Rheumatoid Arthritis

Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency

SCORPION
Start date: November 2011
Phase: Phase 3
Study type: Interventional

Vitamin D plays a key role in the regulation of calcium metabolism and bone physiology and also presents immunomodulatory effects. In contrast to healthy individuals, macrophages and synoviocytes synovium of patients with rheumatoid arthritis (RA) have receptors for vitamin D. In vitro, 1,25 Vitamin D inhibits T cell proliferation and cytokine synthesis and decreases pro-inflammatory process. There is an inverse relationship, at least in some epidemiological studies, between the circulating levels of 25OH vitamin D and the occurrence and / or activity of RA. The hypothesis of our study is that natural vitamin D supplementation in patients with RA and a vitamin D deficiency (vitamin D <30 ng / mL) improves functional disability.

NCT ID: NCT02087683 Recruiting - Heart Failure Clinical Trials

Effect of Vitamin D Supplementation in Patients With Heart Failure and Vitamin D Deficiency

Start date: November 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effects of vitamin D supplementation in patients with heart failure and vitamin D deficiency on ventricular function, inflammatory cytokines, brain natriuretic peptide, lipid profile, glucose, serum insulin, serum parathyroid hormone and calcium.

NCT ID: NCT01807845 Recruiting - Clinical trials for Vitamin D Deficiency

Bioavailability of Vitamin D Encapsulated in Casein Micelles, Compared to Its Bioavailability in a Synthetic Emulsifier Currently Used for Supplementation and Enrichment.

VD
Start date: January 2013
Phase: N/A
Study type: Interventional

Background: Vitamin D3 (VD) is an oil soluble vitamin formed in the skin during exposure to UV light. It is essential for bone and calcium metabolism, insulin reactivity, immune system etc. The dietary sources of VD are scarce, and insufficient. Epidemiological studies link proper VD status with lower risks of bone fracture, hypertension, diabetes, cancer and more. VD deficiency is widespread, mainly due to avoidance of sun exposure due to fear of melanoma. Therefore there is an urgent need to enrich staple foods & beverages with VD, to prevent deficiency. A novel technology was developed , for nanoencapsulating VD within casein micelles (CM) (natural milk protein nanoparticles). Previously we have found that the bioavailability of VD in CM in 1% fat milk was similar to that in an aqueous dietary supplement based on a synthetic emulsifier- Tween 80- which is sometimes used by the industry to add VD into milk. The main research question studied in the current project is: how will the bioavailability of VD be affected by its delivery in CM compared to its delivery using Tween 80 in a fat free milk product, like nonfat yogurt. Hypothesis: The open molecular structure of caseins, which evolved to be easily digestible, may facilitate the bioavailability of VD nanoencapsulated in CM, so that it will not be less than that in Tween 80, which is considered to be good. CM are particularly useful for oil-soluble micronutrient delivery in non-fat products. The most widely consumed nonfat milk product is 0% fat yoghurt, chosen it for this study. Methods: Yoghurts will be made from 3 milk formulations: 1. Skim milk (0% fat) enriched with 50,000 international units (IU) VD in 150 gr product, in CM. 2. Skim milk with same dosage of VD, emulsified with Tween 80. 3. Placebo: skim milk without added VD. 90 healthy adults, aged 18-65, having passed a medical qualification examination, will be randomly assigned to 3 groups. Following over-night fasting they will each consume a 150 gr yoghurt sample as detailed above, and be requested to fast 2 more hours. Blood will be sampled before yoghurt consumption, and after 1, 7 and 14 days following consumption. Blood-serum level of 25(OH)D (the form of VD used as a status indicator in routine blood tests), by chemiluminescence immunoassay (CMIA). Expected findings: The bioavailability of VD in CM will not be lower than that in Tween 80, in 0% fat yoghurt. Significance of the study: With the widespread VD deficiency, decreased fat consumption and rising demand for using only natural ingredients there is great importance in delivery of VD and other fat-soluble micronutrients in protein-based delivery systems, like CM, instead of using synthetic emulsifiers, and it is imperative to assure the bioavailability is not compromised by this dramatic change. CM solubilize VD and help uniformly distribute it in aqueous products and protect it against heat, oxidation and UV.

NCT ID: NCT01754961 Recruiting - Clinical trials for Vitamin D Deficiency

Effects of Vitamin D on Inflammation in Liver Disease

Start date: November 2011
Phase: Phase 2
Study type: Interventional

Chronic liver diseases are associated with inflammation. The investigators postulate that Vitamin D may modulate inflammation. Thus the investigators will study the effect of Vitamin D replacement in patients with Hepatitis C infection and Vitamin D deficiency.

NCT ID: NCT01705522 Recruiting - Ulcerative Colitis Clinical Trials

Multimodal Approach in IBD Patients

MAID
Start date: October 2012
Phase:
Study type: Observational

The investigators intend to assess the role of several biomarkers in the prediction of relapse in IBD. Clinical, laboratory and endoscopic data will be gathered and a predictive score will be derived in order to assess the relapse risk at 1 year.