EVALUATION OF A NEW SOLID FORMULATION OF CALCIUM AND VITAMIN-D IN INSTITUTIONALIZED ELDERLY SUBJECTS

Supplementation with 800 IU of vitamin D and 1 g of calcium each day i s recommended in institutionalized elderly subjects to prevent seconda ry hyperparathyroidism and its adverse skeletal effects. An original f ormulation (IDEOS(R)) combining vitamin D and calcium has been develop ed for use in this end. The aim of this study was to determine whether administration of this association, of which each tablet contains 500 mg calcium and 400 IU vitamin D3, produces the same beneficial effect s on laboratory parameters as separate administration of both active a gents. A multicenter randomized study was conducted in 91 elderly inst itutionalized subjects (mean age 83.1 years) who had vitamin D deficie ncy [25-(OH)D < 6 ng/ml] without severe renal failure. Subjects were r andomly assigned to one of the two treatment groups. Treatment duratio n was six months. One group (G1, n = 46) received one tablet of the ne w formulation twice daily. The other (G2, n = 45) received 8 drops of vitamin D3 (800 IU/day) and one calcium carbonate 500 mg tablet twice daily. Blood tests were carried out at inclusion and after three and s ix months of treatment. In group G1, plasma 25-(OH)D levels increased from 2.6 ng/ml at inclusion to 14.6 ng/ml at month 6 (p < 0.001), and iPTH fell from 63.2 pg/ml at inclusion to 33.8 pg/ml at month 6 (p < 0 .001). In group G2, 25-(OH)D rose from 2.8 ng/ml at inclusion to 13.5 ng/ml at month 6 (p < 0.001), and iPTH fell from 55.4 pg/ml at inclusi on to 32.5 pg/ml at month 6 (p < 0.001). Serum calcium levels increase d slightly in both groups, without exceeding the accepted normal range . Both treatments were well tolerated but acceptability by the patient s was better for the new formulation (p=0.038). Our data demonstrate t hat the new formulation is as effective in correcting vitamin D defici ency and secondary hyperparathyroidism in elderly subjects as separate administration of both its active ingredients. Patients given the new formulation were more likely to express satisfaction with their treat ment regimen than patients given calcium and vitamin D as two separate medications.