Evaluation of a new solid formulation of calcium and vitamin D in institutionalized elderly subjects. A randomized comparative trial versus separate administration of both constituents.
Supplementation with 800 IU of vitamin D and 1 g of calcium each day is recommended in institutionalized elderly subjects to prevent secondary hyperparathyroidism and its adverse skeletal effects. An original formulation (IDEOS) combining vitamin D and calcium has been developed 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 effects on laboratory parameters as separate administration of both active agents. A multicenter randomized study was conducted in 91 elderly institutionalized subjects (mean age 83.1 years) who had vitamin D deficiency [25-(OH)D < 6 ng/ml] without severe renal failure. Subjects were randomly assigned to one of the two treatment groups. Treatment duration was six months. One group (G1, n = 46) received one tablet of the new 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 six 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 inclusion to 32.5 pg/ml at month 6 (p < 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)
Sebert
J L
JL
Rheumatology Department, North Hospital, Amiens, France.
Garabedian
M
M
Chauvenet
M
M
Maamer
M
M
Agbomson
F
F
Brazier
M
M
D000368:Aged; D000369:Aged, 80 and over; D000469:Alkaline Phosphatase / Q000097:blood; D002118:Calcium / Q000032:analysis / Q000172:deficiency*; D002119:Calcium Carbonate / Q000008:administration & dosage*; D002762:Cholecalciferol / Q000008:administration & dosage*; D003404:Creatinine / Q000378:metabolism; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006887:Hydroxycholecalciferols / Q000097:blood; D006962:Hyperparathyroidism, Secondary / Q000517:prevention & control*; D008297:Male; D010281:Parathyroid Hormone / Q000097:blood; D014808:Vitamin D Deficiency / Q000188:drug therapy*
D004338:Drug Combinations; D006887:Hydroxycholecalciferols; D010281:Parathyroid Hormone; D002762:Cholecalciferol; D003404:Creatinine; D000469:Alkaline Phosphatase; D002119:Calcium Carbonate; D002118:Calcium