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High Dosage Vitamin D and Osteoporosis

07:28 EDT 31st July 2014 | BioPortfolio

Summary

Vitamin D and calcium are essential in the treatment and prevention of osteoporosis. What dosage of vitamin D which is the ideal one, is not yet clear. We want to test the hypothesis that high dosage of vitamin D (i.e. 6500 IU/d) is better than standard dosage (800 IU/d) in a randomized double-blind trial. We will include 400 postmenopausal otherwise healthy women with T-score <= -2.0 in L2-4 or mean total hip. Everybody will receive calcium 1000 mg and vitamin D 800 IU every day. Half of the group will also receive vitamin D 40 000 IU/week, while the other half will have placebo. The study period is one year.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Osteoporosis

Intervention

cholecalciferol (Vitamin D3), placebo

Location

Medical Dpt. B, University Hospital of Northern Norway
Tromsø
Norway
9012

Status

Active, not recruiting

Source

University Hospital of North Norway

Results (where available)

View Results

Links

Clinical Trials [760 Associated Clinical Trials listed on BioPortfolio]

Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy

Vitamin D is available in two forms, vitamin D2 and vitamin D3. It has previously been assumed that these two forms maintain blood vitamin D equally. However, this may not be the case....

A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D

This study will evaluate the bioequivalence of alendronate in combination with vitamin D (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in combination...

A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis

A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density, improve biochemical markers of bone turnover, and reduce the number of falls as com...

Vitamin D3 for the Treatment of Low Vitamin D in Cystic Fibrosis

Vitamin D deficiency is common in cystic fibrosis. Vitamin D deficiency frequently persists despite aggressive treatment with ergocalciferol, a vitamin D preparation also known as vitamin...

Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease

Will oral vitamin improve strength, bone quality, pain and quality of life. This is a double blind, randomized placebo controlled study using 10,000 IU of cholecalciferol vs placebo.

PubMed Articles [2719 Associated PubMed Articles listed on BioPortfolio]

Disparity in cholecalciferol content of commercial preparations available in India.

High prevalence of vitamin D deficiency (VDD) has been reported throughout the India for all age groups. Increased awareness about VDD among treating physicians has led to increased prescriptions of v...

Effect of vitamin D supplementation on cathelicidin, IFN-γ, IL-4 and Th1/Th2 transcription factors in young healthy females.

OBJECTIVES:We assessed the effect of cholecalciferol and calcium supplementation on mRNA expression of cathelicidin (LL-37), Th1 and Th2 cytokines and their transcription factors in the peripheral blo...

Activation of FGF-23 Mediated Vitamin D Degradative Pathways by Cholecalciferol.

Context: The optimal circulating concentration of 25(OH) vitamin D is controversial. Objective: To investigate if FGF-23 and 24,25(OH)2D can guide cholecalciferol replacement. Design: Oral cholecalcif...

Impact of oral vitamin D (cholecalciferol) replacement therapy on blood pressure in type 2 diabetes patients; a randomized, double-blind, placebo controlled clinical trial.

Background: Vitamin D is an important mediator of calcium metabolism. It has also been implicated as a potential contributor to the pathophysiology of various extra-skeletal conditions, consisting hyp...

Vitamin D insufficiency in osteoporotic hip fracture patients: rapid substitution therapy with high dose oral cholecalciferol (vitamin D3).

Assessment and treatment of osteoporosis are recommended following hip fracture. Osteoporosis treatment assumes an adequate calcium intake and a normal vitamin D plasma level. The authors conducted a...

Medical and Biotech [MESH] Definitions

Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.

Hydroxy analogs of vitamin D 3; (CHOLECALCIFEROL); including CALCIFEDIOL; CALCITRIOL; and 24,25-DIHYDROXYVITAMIN D 3.

A lipid cofactor that is required for normal blood clotting. Several forms of vitamin K have been identified: VITAMIN K 1 (phytomenadione) derived from plants, VITAMIN K 2 (menaquinone) from bacteria, and synthetic naphthoquinone provitamins, VITAMIN K 3 (menadione). Vitamin K 3 provitamins, after being alkylated in vivo, exhibit the antifibrinolytic activity of vitamin K. Green leafy vegetables, liver, cheese, butter, and egg yolk are good sources of vitamin K.

A nutritional condition produced by a deficiency of VITAMIN D in the diet, insufficient production of vitamin D in the skin, inadequate absorption of vitamin D from the diet, or abnormal conversion of vitamin D to its bioactive metabolites. It is manifested clinically as RICKETS in children and OSTEOMALACIA in adults. (From Cecil Textbook of Medicine, 19th ed, p1406)

A nonhormonal medication for the treatment of postmenopausal osteoporosis in women. This drug builds healthy bone, restoring some of the bone loss as a result of osteoporosis.

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