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Clinical and laboratory safety of one year's use of a combination calcium + vitamin D tablet in ambulatory elderly women with vitamin D insufficiency: results of a multicenter, randomized, double-blind, placebo-controlled study.
Clin Ther. 2005 Dec; 27(12):1885-93.CT

Abstract

OBJECTIVE

This article presents the results of an evaluation of the clinical and laboratory safety of a 1-year course of treatment with a combination calcium and vitamin D tablet in ambulatory women aged >65 years with vitamin D insufficiency.

METHODS

In a multicenter, randomized, double-blind, placebo-controlled study conducted in France, women with a 25-hydroxyvitamin D level < or =12 ng/mL were randomized to receive either a combination tablet containing calcium carbonate 500 mg and vitamin D3 400 IU taken twice daily or a matching placebo tablet for 1 year. A complete clinical examination was performed at baseline and at 3, 6, 9, and 12 months of treatment; blood and urine samples were collected for laboratory analyses at the same time points. Safety was monitored based on adverse events recorded during the treatment period and on the results of laboratory tests, including measurement of creatinine and uric acid levels.

RESULTS

The study included 192 women (mean [SD] age, 74.6 [6.9] years; mean weight, 64.0 [12.5] kg), 95 in the calcium + vitamin D group and 97 in the placebo group. Fifty women (21/95 [22.1%] calcium + vitamin D, 29/96 [30.2%] placebo) were prematurely withdrawn from the study for various reasons, with no difference in withdrawals between groups. Treatment-related adverse events were reported in 21 (22.1%) and 23 (24.0%) women in the respective treatment groups. These events consisted mainly of metabolic disorders (9 [9.5%] and 10 [10.4%], respectively), particularly hypercalcemia (6 [6.3%] and 8 [8.3%]) and gastrointestinal disorders (9 [9.5%] and 8 [8.3%]). No major complications directly related to calcium and vitamin D supplementation occurred during the course of treatment. Although renal function was not altered, the group who received calcium + vitamin D had significantly elevated concentrations of serum uric acid compared with those who received placebo (52.3% vs 37.2%; P = 0.046) but not urinary uric acid.

CONCLUSIONS

In these ambulatory elderly women with vitamin D deficiency, supplementation with calcium + vitamin D appeared to be well tolerated over 1 year of treatment. No significant effects on creatinine clearance were observed. However, the proportion of women with elevated serum uric acid concentrations was significantly greater in those who received calcium + vitamin D compared with those who received placebo.

Authors+Show Affiliations

Department of Rheumatology, Hôpital Nord, Amiens, France.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16507374

Citation

Brazier, Michel, et al. "Clinical and Laboratory Safety of One Year's Use of a Combination Calcium + Vitamin D Tablet in Ambulatory Elderly Women With Vitamin D Insufficiency: Results of a Multicenter, Randomized, Double-blind, Placebo-controlled Study." Clinical Therapeutics, vol. 27, no. 12, 2005, pp. 1885-93.
Brazier M, Grados F, Kamel S, et al. Clinical and laboratory safety of one year's use of a combination calcium + vitamin D tablet in ambulatory elderly women with vitamin D insufficiency: results of a multicenter, randomized, double-blind, placebo-controlled study. Clin Ther. 2005;27(12):1885-93.
Brazier, M., Grados, F., Kamel, S., Mathieu, M., Morel, A., Maamer, M., Sebert, J. L., & Fardellone, P. (2005). Clinical and laboratory safety of one year's use of a combination calcium + vitamin D tablet in ambulatory elderly women with vitamin D insufficiency: results of a multicenter, randomized, double-blind, placebo-controlled study. Clinical Therapeutics, 27(12), 1885-93.
Brazier M, et al. Clinical and Laboratory Safety of One Year's Use of a Combination Calcium + Vitamin D Tablet in Ambulatory Elderly Women With Vitamin D Insufficiency: Results of a Multicenter, Randomized, Double-blind, Placebo-controlled Study. Clin Ther. 2005;27(12):1885-93. PubMed PMID: 16507374.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical and laboratory safety of one year's use of a combination calcium + vitamin D tablet in ambulatory elderly women with vitamin D insufficiency: results of a multicenter, randomized, double-blind, placebo-controlled study. AU - Brazier,Michel, AU - Grados,Franck, AU - Kamel,Saïd, AU - Mathieu,Marc, AU - Morel,Alain, AU - Maamer,Mohamed, AU - Sebert,Jean-Luc, AU - Fardellone,Patrice, PY - 2005/10/03/accepted PY - 2006/3/2/pubmed PY - 2006/4/12/medline PY - 2006/3/2/entrez SP - 1885 EP - 93 JF - Clinical therapeutics JO - Clin Ther VL - 27 IS - 12 N2 - OBJECTIVE: This article presents the results of an evaluation of the clinical and laboratory safety of a 1-year course of treatment with a combination calcium and vitamin D tablet in ambulatory women aged >65 years with vitamin D insufficiency. METHODS: In a multicenter, randomized, double-blind, placebo-controlled study conducted in France, women with a 25-hydroxyvitamin D level < or =12 ng/mL were randomized to receive either a combination tablet containing calcium carbonate 500 mg and vitamin D3 400 IU taken twice daily or a matching placebo tablet for 1 year. A complete clinical examination was performed at baseline and at 3, 6, 9, and 12 months of treatment; blood and urine samples were collected for laboratory analyses at the same time points. Safety was monitored based on adverse events recorded during the treatment period and on the results of laboratory tests, including measurement of creatinine and uric acid levels. RESULTS: The study included 192 women (mean [SD] age, 74.6 [6.9] years; mean weight, 64.0 [12.5] kg), 95 in the calcium + vitamin D group and 97 in the placebo group. Fifty women (21/95 [22.1%] calcium + vitamin D, 29/96 [30.2%] placebo) were prematurely withdrawn from the study for various reasons, with no difference in withdrawals between groups. Treatment-related adverse events were reported in 21 (22.1%) and 23 (24.0%) women in the respective treatment groups. These events consisted mainly of metabolic disorders (9 [9.5%] and 10 [10.4%], respectively), particularly hypercalcemia (6 [6.3%] and 8 [8.3%]) and gastrointestinal disorders (9 [9.5%] and 8 [8.3%]). No major complications directly related to calcium and vitamin D supplementation occurred during the course of treatment. Although renal function was not altered, the group who received calcium + vitamin D had significantly elevated concentrations of serum uric acid compared with those who received placebo (52.3% vs 37.2%; P = 0.046) but not urinary uric acid. CONCLUSIONS: In these ambulatory elderly women with vitamin D deficiency, supplementation with calcium + vitamin D appeared to be well tolerated over 1 year of treatment. No significant effects on creatinine clearance were observed. However, the proportion of women with elevated serum uric acid concentrations was significantly greater in those who received calcium + vitamin D compared with those who received placebo. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/16507374/Clinical_and_laboratory_safety_of_one_year's_use_of_a_combination_calcium_+_vitamin_D_tablet_in_ambulatory_elderly_women_with_vitamin_D_insufficiency:_results_of_a_multicenter_randomized_double_blind_placebo_controlled_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(05)00322-X DB - PRIME DP - Unbound Medicine ER -