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Vitamin D and Calcium Supplement Attenuate Bone Loss among HIVInfected Patients Receiving Tenofovir Disoproxil Fumarate/Emtricitabine/ Efavirenz: An Open-Label, Randomized Controlled Trial.
Boontanondha, P, Nimitphong, H, Musikarat, S, Ragkho, A, Kiertiburanakul, S
Current HIV research. 2020;(1):52-62
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Abstract
BACKGROUND Antiretroviral therapy (ART), especially with tenofovir disoproxil fumarate (TDF), has been associated with accelerated bone turnover and leads to significant bone loss. OBJECTIVE We aimed to determine the effect of vitamin D2 and calcium on bone mineral density (BMD) in HIV-infected patients receiving TDF/emtricitabine (FTC)/efavirenz (EFV). METHODS A prospective, open-label, randomized controlled study was conducted. Eligible patients were ART naïve HIV individuals who initiated TDF/FTC/EFV. The study group received supplementation with vitamin D2 and calcium carbonate, whereas the control group was administered only ART. The primary outcome was the percentage change in total hip BMD at week 24 compared with baseline. RESULTS A total of 18 patients were randomized (9 in each group). The mean (standard deviation; SD) total hip BMD significantly decreased from baseline in both groups, from 0.96 (0.14) g/cm2 to 0.93 (0.13) g/cm2 in the study group (p = 0.006) and from 0.87 (0.11) g/cm2 to 0.84 (0.11) g/cm2 in the control group (p = 0.004). The mean (SD) lumbar spine BMD significantly decreased from baseline in both groups, from 1.00 (0.13) g/cm2 to 0.97 (0.13) g/cm2 (p = 0.004) in the study group and from 0.90 (0.09) g/cm3 to 0.86 (0.08) g/cm2 in the control group (p = 0.006). At week 24, the mean (SD) lumbar spine BMD was significantly greater in the study group than in the control group (p = 0.042). However, there were no significant differences in the percentage change of total hip, lumbar spine, and femoral neck BMD between both groups. No adverse events were reported. In conclusion, as early as 24 weeks after TDF initiation, a significant decline in BMD was detected. CONCLUSION Vitamin D2 and calcium supplements should be considered for HIV-infected patients receiving TDF/FTC/EFV in a resource-limited setting where there are limited ART options (Clinicaltrials. gov NCT0287643).
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Comparison of sevelamer and calcium carbonate on endothelial function and inflammation in patients on peritoneal dialysis.
Chennasamudram, SP, Noor, T, Vasylyeva, TL
Journal of renal care. 2013;(2):82-9
Abstract
BACKGROUND Hyperphosphataemia is a known independent risk factor for cardiovascular mortality. The objective of the study was to compare the effects of two phosphate binders, sevelamer carbonate and calcium carbonate on endothelial function (EF) and inflammation in patients on peritoneal dialysis (PD) with Type 2 diabetes mellitus (T2DM). METHODS Fifteen subjects with hyperphosphataemia discontinued all phosphate binders to undergo a two-week washout and were assigned to sevelamer carbonate or calcium carbonate treatments for eight weeks. After a second two-week washout period, subjects crossed over to either of the alternate treatments for another eight weeks. At the beginning and end of each treatment, biomarkers of EF, pro-inflammatory cytokines, serum albumin, calcium, phosphate and lipids were measured. RESULTS Sevelamer carbonate significantly improved lipid profile compared with calcium carbonate. Amongst the EF and pro-inflammatory biomarkers, sevelamer carbonate decreased serum endothelin-1, plasminogen activator inhibitor-1, C-reactive protein and interleukin-6. Both phosphate binders were effective in decreasing serum phosphate but sevelamer had a positive effect on EF. CONCLUSIONS Treatment with sevelamer carbonate has beneficial effects compared with calcium carbonate in decreasing inflammation and improving EF in patients with T2DM on PD.
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The effect of inactivated Lactobacillus LB fermented culture medium on symptom severity: observational investigation in 297 patients with diarrhea-predominant irritable bowel syndrome.
Tarrerias, AL, Costil, V, Vicari, F, Létard, JC, Adenis-Lamarre, P, Aisène, A, Batistelli, D, Bonnaud, G, Carpentier, S, Dalbiès, P, et al
Digestive diseases (Basel, Switzerland). 2011;(6):588-91
Abstract
INTRODUCTION Little is known about the intensity of symptoms of diarrhea-predominant IBS (IBS-D) or the consequences of the disease on patients' health-related quality of life (HRQOL). This observational investigation assessed the symptoms (abdominal pain, bloating, number of stools per day, and stool consistency), impact on HRQOL, and consequence on anal continence in 297 patients with IBS-D before and after 1 month of probiotic treatment with Lacteol (inactivated Lactobacillus LB plus fermented culture medium). METHODS Functional assessment using a standardized visual analogue scale in order to quantify abdominal pain, bloating, and quality of life before and after 1 month of treatment with 2 capsules/day of Lacteol. The number of symptomatic days per week, number of stools, consistency of stools, secondary fecal incontinence rate, and potential trigger effect of food were quantified. A χ2 test was used to compare qualitative data and the variance of quantitative criteria was analyzed. RESULTS The pain score decreased from 4.46±0.15 on a scale of 0-10 before treatment to 2.8±0.14 after treatment (p<0.0001). Bloating decreased from 4.49±0.18 to 2.5±0.15 on a scale of 0-10 (p<0.0001). The HRQOL score, which is inversely correlated with quality of life, decreased from 5.99±0.14 to 3.92±0.16 (p<0.0001). In this cohort study, the fecal incontinence rate secondary to diarrhea was clearly higher than that of the general population: 18% versus a prevalence of 9-10%, according to different studies. The mean number of stools per week decreased from 17.59 to 12.83 after treatment (p<0.0001). Before treatment, 54% of patients had watery stools and 46% had smooth stools; at the end of treatment, only 18.5% of patients still had watery stools, and 34% had normal stools. 52% of patients attributed their symptoms to their diet: 34% to vegetables, 29% to fruit, 15% to milk, 15% to fat, 6% to peppers and spices, and 4% to sugar. CONCLUSION This observational investigation shed new light on patients with IBS-D, the HRQOL of which is altered by a fecal incontinence rate twice as high as that of the general population. Correlation with diet is confirmed by 1 out of 2 patients reporting poor tolerance of fiber and dairy products. Nutritional management should thus be part of these patients' treatment. Inactivated Lactobacillus LB plus fermented culture medium is a probiotic drug that has been used by physicians for a long time to treat patients with diarrhea. Strongly concentrated, it has no side effects and seems to help these patients. Due to a strong placebo effect in patients with this pathology, however, a controlled study is necessary to confirm this result.
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Calcium load during administration of calcium carbonate or sevelamer in individuals with normal renal function.
Heinrich, T, Heidt, H, Hafner, V, Schmidt-Gayk, H, Jenetzky, E, Walter-Sack, I, Mikus, G, Bommer, J
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2008;(9):2861-7
Abstract
BACKGROUND Under steady-state conditions urinary calcium (Ca) excretion corresponds to the Ca load in healthy subjects. However, in chronic haemodialysis patients reliable data on Ca load are not available. In these patients Ca-containing phosphate binders are suspected to play a role in the progression of arteriosclerosis via increased but not quantified Ca load. The present study evaluated the effect of calcium carbonate (CC) and sevelamer hydrochloride (SEV), a calcium-free phosphate binder, on serum Ca and urinary Ca excretion in healthy individuals. METHODS Twelve healthy male individuals were included in a monocentre, randomized, single-blind, placebo-controlled, three-way crossover phase I study. Concurrently with their meals, participants received 4 x 2 tablets of SEV (800 mg), CC (500 mg) or placebo for 6 days with 1-week washout between the treatment periods. During the study, weekly blood samples were taken and 24-h urine was collected each day for measurement of calcium, magnesium, phosphorus, chloride and iPTH. RESULTS Mean daily urinary phosphorus excretion was significantly lower in subjects undergoing SEV treatment compared to those taking placebo (P < 0.001). Mean daily total urinary excretion of calcium was significantly higher in CC-treated participants compared to those receiving placebo (P < 0.001). Mean 24-h calcium excretion during the 6 treatment days was 6.60 +/- 2.62 mmol [265 +/- 105 mg] (CC) versus 5.15 +/- 2.16 mmol [206 +/- 87 mg] (SEV) versus 4.95 +/- 1.63 mmol [198 +/- 65 mg] (Placebo). Taking into account nutritional calcium intake estimated from dietary records fractional calcium absorption was 8.7% (CC), 13.3% (placebo) and 14.8% (sevelamer). CONCLUSION Intake of calcium carbonate compared to placebo in contrast to sevelamer in healthy individuals was associated with increased total urinary calcium excretion indicating an increased calcium load due to increased intestinal calcium absorption.
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Effectiveness and safety of Lactobacillus LB in the treatment of mild acute diarrhea in children.
Salazar-Lindo, E, Figueroa-Quintanilla, D, Caciano, MI, Reto-Valiente, V, Chauviere, G, Colin, P, ,
Journal of pediatric gastroenterology and nutrition. 2007;(5):571-6
Abstract
BACKGROUND Acute diarrhea is an important cause of morbidity and mortality in children. Oral rehydration salts (ORS) have lowered mortality without having an effect on the duration or severity of diarrhea. Some studies have reported that heat-killed Lactobacillus bacteria have a beneficial effect in the treatment of acute diarrhea. In this placebo-controlled study the duration of diarrhea was compared for 2 types of treatment: Lactobacillus LB (Lacteol) in association with oral rehydration and oral rehydration alone. PATIENTS AND METHODS A total of 80 nondehydrated children between the ages of 3 months and 4 years with acute watery diarrhea were randomly assigned to be treated with Lactobacillus LB or placebo plus ORS. The primary endpoint was the duration of diarrhea; intake of ORS and change in body weight between the time of randomization and the last assessment were also measured. RESULTS In 71 of the 80 patients, diarrhea was resolved: 36 in the Lactobacillus LB group and 35 in the placebo group. Several clinical characteristics of the 2 treatment groups were comparable at baseline. Median duration of diarrhea was 16.6 hours in the placebo group compared with 10.0 hours in the Lactobacillus LB group (P = 0.275). In the subgroup with a duration of diarrhea of more than 24 hours at inclusion, duration of diarrhea measured from that point was shorter for the Lactobacillus LB group (30.4 h vs 8.2 h; P = 0.044). ORS intake was similar for both groups. Lactobacillus LB was well tolerated, with only one patient experiencing an adverse effect. CONCLUSIONS Lactobacillus LB is an effective and safe treatment for children with well-established diarrhea (>24 h).
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Two year comparison of sevelamer and calcium carbonate effects on cardiovascular calcification and bone density.
Asmus, HG, Braun, J, Krause, R, Brunkhorst, R, Holzer, H, Schulz, W, Neumayer, HH, Raggi, P, Bommer, J
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2005;(8):1653-61
Abstract
BACKGROUND Calcium-based phosphate binders may induce tissue calcification, and little is known about their effects on bone density. We compared the effects of a calcium with a non-calcium phosphate binder on both arterial calcification and bone density measured by computed tomography. METHODS Seventy-two adult haemodialysis patients were randomized to treatment with calcium carbonate (CC) or sevelamer (SEV) for 2 years. Electron beam CT scans were performed at baseline and at 6, 12 and 24 months. Serum phosphorus, calcium, calcium x phosphorus product and intact parathyroid hormone (iPTH) were measured and other routine laboratory tests were also carried out. RESULTS The average calcium x phosphorus product was similar in the two treatment groups. However, patients receiving CC had significantly lower average iPTH (P<0.01), were more likely to have hypercalcaemic episodes (P = 0.03) and had significantly greater increases in coronary artery (CC median 484, P<0.0001, SEV median 37, P = 0.3118, between-group P = 0.0178) and aortic (CC median 610, P = 0.0003, SEV median 0, P = 0.5966, between-group P = 0.0039) calcification scores. The CC group also had a significant decrease in trabecular bone density (CC median -6%, P = 0.0049, SEV median +3%, P = 0.0296, between-group P = 0.0025). However, there was no significant difference in cortical bone density between the two groups. CONCLUSIONS This 2 year study shows that calcium carbonate use is continuously associated with progressive arterial calcification in haemodialysis patients. In addition, it suggests that it is also associated with decreased trabecular bone density. However, this latter finding requires confirmation by a study specifically devoted to this issue.
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Prevention of bone loss after allogeneic stem cell transplantation by calcium, vitamin D, and sex hormone replacement with or without pamidronate.
Kananen, K, Volin, L, Laitinen, K, Alfthan, H, Ruutu, T, Välimäki, MJ
The Journal of clinical endocrinology and metabolism. 2005;(7):3877-85
Abstract
CONTEXT In controlled studies, bisphosphonates have been used to prevent bone loss after solid organ transplantations but not in conjunction with stem cell transplantation (SCT). OBJECTIVE The objective of the study was to test whether additional iv pamidronate would prevent bone loss associated with SCT more effectively than the combination of calcium, vitamin D, and sex steroid replacement therapy alone. SETTING The study was carried out at the Helsinki University Central Hospital. PATIENTS, DESIGN, INTERVENTION Ninety-nine adult recipients of allogeneic SCT were randomized by age and gender into two groups. In one group, the patients received 1000 mg calcium carbonate and 800 IU vitamin D daily, and females received estrogen and males received testosterone replacement therapy. In another group, the patients received the same treatments plus six iv infusions of 60 mg pamidronate before and 1, 2, 3, 6, and 9 months after SCT. MAIN OUTCOME MEASURES Bone mineral density (BMD) of the lumbar spine and the upper femur, measured by dual-energy x-ray absorptiometry, and bone turnover markers were followed for 12 months. RESULTS In the pamidronate group, lumbar spine BMD remained stable but decreased in the other group by 2.9% at 12 months (P = 0.0084 between the groups over time). Total hip BMD reduced 5.1% in the pamidronate group and 7.8% in the other group by 12 months (P = 0.0015), and femoral neck BMD reduced 4.2 and 6.2%, respectively (P = 0.074). In the pamidronate group, serum type I procollagen amino-terminal propeptide (P = 0.032 between the groups over time) and urinary type I collagen amino-terminal telopeptide (P = 0.035) decreased 79 and 68% during the first 3 months, and remained lowered thereafter, but did not change in the other group. CONCLUSIONS The recipients of allogeneic SCT receiving additional pamidronate sustain less bone loss than those treated with calcium, vitamin D, and sex steroid replacement alone. Despite all the efforts, however, bone loss is not totally abolished at the hip.
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[Clinical analysis of time-course changes in minerals and parathyroid hormone levels during treatment with phosphate binders in hemodialysis patients with secondary hyperparathyroidism].
Yokoyama, T, Onodera, Y, Mano, T
Clinical calcium. 2005;:125-30; discussion 130-1
Abstract
146 hemodialysis (HD) patients with secondary hyperparathyroidism (2 degrees HPT) were studied about the therapeutic effects of phosphate binders. We divided these patients into four groups; Group I: 59 patients treated with CaCO(3) (1.5-6.0 g/day), Group II: 42 cases with sevelamer hydrochloride (0.75-9.0 g/day), Group III: 30 with both CaCO(3) and sevelamer, Group IV: 15 with both CaCO(3) and cholestimide (1.5-6.0 g/day). These patients were prescribed several phosphate binders for at least 18 months. The serum levels of P, albumin-corrected Ca (Ca), Ca x P product and intact parathyroid hormone (iPTH) were serially determined. In Group I and IV, these four parameters showed no significant difference between at before administration and at after 1, 3, 6 and 12 months. In Group II, the values of iPTH, Ca and Ca x P product between at before sevelamer administration and at after 9 months were 199.43+/-94.40 vs 159.86+/-96.03 pg/mL (p<0.05), 9.48+/-1.12 vs 9.01+/-1.00 mg/dL (p<0.05) and 62.72+/-19.62 vs 50.44+/-25.97 mg(2)/dL(2) (p<0.05), respectively. In Group III, P showed significant decrease from 7.16+/-1.33 to 6.72+/-1.69 mg/dL (p<0.05) between at the time of adding sevelamer to CaCO(3) and at after nine months. These results indicate that sevelamer plays an excellent role in the treatment of 2 degrees HPT mainly by controlling Ca level and the combination therapy with CaCO(3) is useful for improvement of P level in patients undergoing HD.
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Valvular calcification in hemodialysis patients randomized to calcium-based phosphorus binders or sevelamer.
Raggi, P, Bommer, J, Chertow, GM
The Journal of heart valve disease. 2004;(1):134-41
Abstract
BACKGROUND AND AIM OF THE STUDY Valvular calcification is common in patients with end-stage renal disease, and is associated with an unfavorable prognosis. It was hypothesized that sevelamer, a non-calcium-based phosphorus binder, might attenuate the progression of valvular calcification. METHODS Two hundred subjects on maintenance hemodialysis received either sevelamer or calcium-based phosphorus binders. To assess the extent of calcification, 186 subjects underwent baseline electron beam tomography (EBT) of the coronary arteries, aorta and mitral and aortic valves, and 132 had follow up EBT scans at week 52. Changes in valvular calcification and combined valvular/vascular calcification were monitored and compared. RESULTS At baseline, mitral valve calcification was seen in 46% of subjects, aortic valve calcification in 33%. Most subjects with zero values at baseline failed to progress over one year. Aortic valve calcification was significantly increased in calcium-treated subjects. Changes in mitral valve calcification, and combined mitral + aortic valve calcification were less in sevelamer-treated than in calcium-treated subjects, but not significantly so. When combining valvular and vascular calcification, the median (10%, 90%) change in sevelamer-treated subjects was significantly lower than in calcium-treated subjects (6, -5084 to 1180 versus 81, -1150 to 2944, p = 0.04). The effect of sevelamer remained significant after adjustment for baseline calcification and the time-averaged calcium-phosphorus product, and was independent of the calcium preparation (acetate versus carbonate), geographic region (US versus Europe), LDL- or HDL-cholesterol, C-reactive protein and statin use. Significantly more sevelamer-treated subjects experienced an arrest (45 versus 28%, p = 0.047) or regression (26 versus 10%, p = 0.02) in total valvular and vascular calcification. CONCLUSION Sevelamer arrested the progression of valvular and vascular calcification in almost 50% of hemodialysis subjects. Sevelamer treatment, plus intensive control of calcium and phosphorus levels, may attenuate progression of, or achieve regression in, cardiac valvular calcification.
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The effect of calcium supplementation on bone density in premenarcheal females: a co-twin approach.
Cameron, MA, Paton, LM, Nowson, CA, Margerison, C, Frame, M, Wark, JD
The Journal of clinical endocrinology and metabolism. 2004;(10):4916-22
Abstract
The age and developmental stage at which calcium supplementation produces the greatest bone effects remain controversial. We tested the hypothesis that calcium supplementation may improve bone accrual in premenarcheal females. Fifty-one pairs of premenarcheal female twins (27 monozygotic and 24 dizygotic; mean +/- sd age, 10.3 +/- 1.5 yr) participated in a randomized, single-blind, placebo-controlled trial with one twin of each pair receiving a 1200-mg calcium carbonate (Caltrate) supplement. Areal bone mineral density (aBMD) was measured at baseline and 6, 12, 18 and 24 months. There were no within-pair differences in height, weight, or calcium intake at baseline. Calcium supplementation was associated (P < 0.05) with increased aBMD compared with placebo, adjusted for age, height, and weight at the following time points from baseline: total hip, 6 months (1.9%), 12 months (1.6%), and 18 months (2.4%); lumbar spine, 12 months (1.0%); femoral neck, 6 months (1.9%). Adjusted total body bone mineral content was higher in the calcium group at 6 months (2.0%), 12 months (2.5%), 18 months (4.6%), and 24 months (3.7%), respectively (all P < 0.001). Calcium supplementation was effective in increasing aBMD at regional sites over the first 12-18 months, but these gains were not maintained to 24 months.