DARU, Journal of Pharmaceutical Sciences
Volume:17 Issue: 4, winter2010

Background and the purpose of the study: There are increasing evidences about relationship between vitamin D metabolism and occurrence of diabetes mellitus. Vitamin D has a role in secretion and possibly the action of insulin and modulates lipolysis and might therefore contribute to the development of the metabolism. The aim of this study was to investigate the nature and strength of the association between vitamin D concentration and the metabolic syndrome (MS) in Iranian population. A cross-sectional study was conducted on 646 healthy population who had no history of diabetes. The MS was defined according to WHO criteria. The concentrations of vitamin D، and parathyroid hormone (PTH) were also measured. Results and major Of the total 646 participants، the unadjusted prevalence of the MS was 18. 3% (29% in men and 14. 6% in women). The total prevalence of vitamin D deficiency was 72. 3%. Amongst the men with vitamin D deficiency the prevalence of the MS was higher than those with normal vitamin D (p=0. 03). In the logistic regression model، after age and sex adjustment، vitamin D deficiency predicted independently the metabolic syndrome (p=0. 001). Vitamin D deficiency and the MS have a high prevalence among Iranian adult population. The finding of this investigation revealed that vitamin D deficiency may have an important role in metabolic syndrome and its components.

Background and the purpose of the study:The aim of this study was to investigate whether Peripheral blood mononuclear cells from osteoporotic patients have a different expression profile of inflammatory and osteoimmunology markers. In addition, the in vitro anti-inflammatory properties of 1,25(OH)2D3 in osteoporotic patients was assessed. For this purpose, cytokines profile and RANKL/OPG system in osteoporotic patients in comparison with healthy controls was investigated. Monocytes were isolated from peripheral blood of participants by the Ficoll density method, cultured and induced with vitamin D. Cells were harvested several times. RNA was extracted and then cDNA was synthesized. Inflammatory markers (IL-1β, IL- 6 and TNFα), bone metabolism markers (Osteoprotegrin and RANKL), vitamin D receptor (VDR) and β-actin genes were quantified by quantitative real-time reverse transcriptase.Results and major The expressions of the cytokines IL-6, TNF-α, IL-1, were all down regulated by 1,25(OH)2D3 in monocytes of all participants. Monocytes from healthy control in comparison to osteoporotic patients had a clear suppression pattern of inflammatory cytokines upon vitamin D3 incubation. Of noteworthy is that mRNA expressions of inflammatory cytokines in osteoporotic patients were clearly higher than controls. Results indicated that inflammation may have critical role in osteoporosis whereas osteoporotic patients have elevated pro- inflammatory profile. Vitamin D and its receptor may have Immunomodulatory effects in osteoimmunology. This regulatory function of VDR adds substance to the inflammatory theory behind osteoporosis pathogenesis.

Background and the purpose of the study:The molecular and functional basis of the VDR polymorphisms is fundamental to appreciate their potential clinical implications. The rationale of this study was to determine the level of serum vitamin D response to vitamin D intake in different genotypes of VDR (FokI) polymorphism and its effect on the bone turnover in postmenopausal women. The subjects for the study were 312 pre and post-menopausal women aged between 20-75 year randomly selected from the participants of Iranian multicenter osteoporosis study. After an overnight fast, 4ml of peripheral blood was taken and centrifuged to separate serum for measurement of serum parathyroid hormone, 25 hydroxyvitamin D, osteocalcin and cross laps. The FokI polymorphism in exon 2 of the VDR gene was detected by the polymerase chain reaction-restriction fragment length polymorphismResults and major FOKI genotype predicted serum cross laps after adjustment for age, menopausal status, serum vitamin D (p<0.001) but did not find significant prediction regarding serum osteocalcin (p=0.3).Also in this model FOKI genotype predicted serum vitamin D after adjustment for age, menopausal status, calcium and vitamin D intake (p<0.001).VDR gene polymorphism may modifies response to vitamin D intake and predicts bone turnover.

Background and the purpose of the study:Experimental studies have shown that Ns (Nigella sativa) seeds oil can increase bone formation and may have anabolic effects on bone loss. This study was conducted to investigate the beneficial impacts of the oil of Black seeds on bone turnover in osteoporotic postmenopausal women. A placebo controlled pilot study was carried out on 15 postmenopausal osteoporotic women of 48-74 years old. In addition to Calcium-D supplements (2 tablets per day) all participants were randomly received Ns extract (3ml, 0.05 ml/kg/day p. o.) or placebo for 3 months. In all subjects hematological tests were performed and hepatic enzymes, BUN, Cr, Ca, P and plasma bone formation and resorption markers including osteocalcin, bone alkaline phosphatase (Bone-ALP) and carboxy terminal cross linked telopeptide (CTX) was determined before and after 12 weeks of treatment. Twelve participants completed the entire 12 weeks study course of which 5 and 7 women were belonged to Ns and placebo groups respectively. Women in placebo group were significantly older than women in Ns group. There were not significant differences between BMIs, BMD results and plasma levels of bone marker in two groups at the baseline and plasma levels of bone markers between Ns and placebo group at the end of 12 weeks. Alterations from baseline in bone markers levels did not differ significantly between two groups. We did not observe any side effects due to Ns therapy. In this pilot study similar to the previous trial, we failed to show beneficial impact of Ns extract administration for a short time on bone turnover so we don’t suggest it for medicinal application in the osteoporosis condition. Long time duration studies with larger sample size and usage of a more tolerable dosage forms of Black seeds oil should be emphasized for further clarification of its useful anabolic effects on bone metabolism.

Background and the purpose of the study:Parenteral Vitamin D3 is commonly prescribed in some developing countries like Iran and data about its effects on serum 25(OH)D concentration are scanty. Current study was designed to evaluate the effects of different doses of parenteral vitamin D3 on serum 25(OH)D concentration. Forty two healthy volunteer were selected and randomly assigned into 3groups. Groups I and II received 300000 and 600000 units of intramuscular vitamin D3and group III received placebo. Serum 25 (OH)D concentration were evaluated before,2 weeks, 2 months and 4 months after injection.Results and major Serum 25(OH)D in groups I and II were significantly higher than those before injection (<0.001). At the end of the study, serum 25(OH)D concentration in groups I,II, and III were 48.20 ± 28.32 ng/ml, 65.46 ± 33.52 ng/ml, and 14.38±11.14 ng/ml, respectively. Relative frequency of serum 25 (OH) D above 80 ng/l in groups I, II and was %20 and %33.3 respectively. One case in group I and one case in group II (in two sessions) showed 25(OH)D concentration above 100 ng/ml. Vitamin D injection especially at doses higher than 300000 IU may be associated with 25(OH)D concentration higher than the accepted normal values.

Background and the purpose of the study:Adequate intake of fruits and vegetables could be helpful to prevent major non-communicable diseases. Some nutrients abundant in fruits and vegetables have been shown to affect bone health. In the present study effects of increasing fruit and vegetable intake on bone metabolism in postmenopausal women with osteopenia was evaluated. In the present clinical trial 45 postmenopausal osteopenic women, between 50-60 years of age participated. Subjects were randomly assigned to intervention or control groups. Subjects in the control group were asked to continue their own dietary patterns and make no changes in their life style. To increase fruit and vegetable intake in the intervention group, they were given 6 extra servings of fruits and vegetables daily. Serum osteocalcin and crosslaps were measured at baseline and after 12 weeks of intervention. Twenty four hrs food recalls were used to assess dietary intake at baseline, during and at the end of the study. Increasing fruit and vegetable intake for 12 weeks reduced serum osteocalcin by 15% and crosslaps by 4%. The reduction was not statistically significant after adjustment for confounding factors. In 9 subjects of the intervention group, both markers of bone metabolism were reduced by 24 %. Baseline serum levels of both bone markers were significantly higher in these subjects. Increasing fruit and vegetable intake may not reduce bone turnover in postmenopausal osteopenic women, but it may be effective for those who are at higher risk of bone fracture because of higher bone turnover.

Background and the purpose of the study:This study was performed to investigate the effect of green tea extract (GTE) on bone turnover in type 2 diabetes mellitus (T2DM) patients. Totally 72 T2DM patients with stratified randomize method were divided into two interventional and control groups in a double blind placebo- control clinical trial study. GTE, 500mg, and placebo were prescribed three times a day for 8 weeks. Laboratory and anthropometric measurements included fasting blood glucose (FBG), oral glucose tolerance test (G2h), glycosylated hemoglobin A1c (HbA1C) and lipid Profile, fasting serum osteocalcin, crosslaps and insulin, body mass index (BMI) and waist to hip ratio (WHR) before and after intervention.Results and major Assess of GTE effect on the bone markers revealed that change in osteocalsin was almost significant but log osteocalsin had significant alteration in GTE group. We found no significant changes in WHR, BMI, FBG, G2h, Hb1Ac, fasting insulin concentration and crosslaps levels in this group after intervention. Representational evidences demonstrated that decrease in crosslaps level was 10 times in green tea groups compared to the placebo group. Results also showed that improved bone turnover patients had significantly lower FBG and HbA1c levels ratio than non-improved patients as well as had higher fasting insulin concentration in GTE group.Our results suggest that GTE may reduces bone resorption marker more than placebo and probably modifies the bone turnover in T2DM patients.

Background and the purpose of the study:One of the most important complications of diabetes is foot ulcers with a life time risk of 15% among diabetics. The main objectives of this study was to evaluate adverse drug reactions(ADR) of oral and topical application of ANGIPARS, a novel compound applied in treatment of diabetic foot ulcers and also its effect on wound surface area, Ankle Brachial Index(ABI), Toe Brachial Index(TBI) and wound temperature. A total number of 75 diabetic patients who were over 50 years (56.7± 9.7 years) and had foot ulcers without any signs of osteomyelitis were enrolled in this study. A basal wound surface area, ABI, TBI and wound temperature was measured and routine hematological and biochemistry tests were performed. Six weeks and 6 months after simultaneous application of oral and topical forms of ANGIPARS, mentioned parameters were evaluated again and analysis was carried out using standard methods.Results and The mean surface area of the ulcers were 6.05 ± 11.1 cm2 at the baseline and 2.4±6.9 cm2 after six weeks of therapy showing a considerable decrease. A significant rise in ABI and TBI (p<0.05) was observed after 6 weeks of treatment. The results also demonstrated a significant fall in erythrocyte sedimentation rate (ESR) for 45 days after drug administration but no significant changes in the other laboratory tests were observed at this time. No significant side effects or toxicity was reported by the participants during the course of the study. This study showed the immense effect and safety of ANGIPARS on treatment of diabetic foot ulcers.

Background and the purpose of the study: Diabetes mellitus is one of the most common chronic diseases in the world with dreadful complications which not only is debilating for the patients but also puts a big burden on the health system.One of the mechanisms by which the complications of diabetes occur is imbalance in the oxidant-antioxidant equilibrium in the body and therefore many studies have been performed to either correct this equilibrium or delay the occurrence of the complications.In this randomized, double-blind placebo-controlled clinical trial, a total number of 61 subjects were divided into two groups and the antioxidant effects of a novel herbal drug, Semelil,was compared with placebo. Baseline laboratory tests including a complete blood count, fasting blood sugar,lipid profile,fasting plasma insulin, liver and renal function tests plus tumor necrotizing factor α (TNFα) and C-reactive protein (CRP) and homocystein were performed. Total antioxidant power assay, cellular lipid peroxidation assay, and nuclear damage (deoxyguanosine) and carbonly molecules were also measured to help determination of state of antioxidants- oxidants equilibrium in serum.Apart from deoxyguanosine, no significant change was found in TNFα or CRP levels in the studied group who received Semelil. Mechanisms other than antioxidant effects are involved for Semelil in the treatment of diabetic foot ulcers.