CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Randomised double blind placebo controlled trial investigating the effect of calcium and vitamin D supplementation on bone mineral density and bone metabolism in adult patients with cystic fibrosis.

Study design (if review, criteria of inclusion for studies)

RCT

Participants

Patients were invited to participate if they had a BMD Z score of -1 or less in the lumbar spine, proximal femur or distal forearm. 15 CF patients and 15 controls

Interventions

calcium 1 g+vitamin D 800 IU or placebo daily, in addition to their regular vitamin D supplements (900 IU/day).

Outcome measures

BMD and bone biochemical markers were measured before and after 1 year of treatment.

Main results

After 12 months, the treatment group showed a reduced rate of bone loss compared with the control group in the lumbar spine (mean difference 1.9% [CI -0.9% to 4.6%]), total hip (mean difference 0.7% [CI -2.2% to 3.5%]) and distal forearm (mean difference 1.7% [CI -2.2% to 5.5%]), but these changes did not reach statistical significance. There was also a trend towards a reduction in bone turnover in the treatment group.

Authors' conclusions

Calcium and vitamin D supplementation reduced the rate of bone turnover and bone loss in adult patients with cystic fibrosis, but these changes did not reach statistical significance. These data suggest that a longer term trial of this simple intervention would be justified.

Keywords: Adolescent; Adult; Bone Density Conservation Agents; Bone Diseases; Calcium; Oral; pharmacological_intervention; placebo; Supplementation; vitamins; Vitamin D; Vitamins; Minerals;