Efectos del calcio y la vitamina D con y sin lactulosa en la densidad mineral ósea de mujeres postmenopáusicas con osteopenia: Ensayo piloto controlado y aleatorizado

Abstract

We report the results of a randomized, double-blind, double-dummy, multicenter, parallel group pilot study, the objective of which was to assess whether the addition of lactulose to vitamin D and calcium supplementation for 12 months contributed to bone mineral density (BMD) maintenance in postmenopausal women with osteopenia (T-score-1 to-2.5 SD). Women in the lactulose group (n=19) received lactulose 15 mL/day (equivalent to 10.05 g), vitamin D3 400 IU/day and calcium carbonate 500 mg/day, and women (n=22) in the placebo group were administered lactulose placebo, vitamin D3 400 IU/day and calcium carbonate 1,000 mg/day. The baseline daily calcium intake was similar in both study groups. The primary endpoint was the BMD in the lumbar spine at the final visit. A generalized liner model was used to assess final versus baseline differences in BMD in both study groups. Differences in least-square means of BMD between lactulose and placebo were not statistically significant both in the per-protocol data set (-0.012, 95% CI-0.031 to 0.007, P=0.224) and in the intention-to-treat population (-0.005, 95% CI-0.025 to 0.016, P=651). As we have not found differences within the two study groups, the addition of lactulose to 500 mg of calcium carbonate associated with vitamin D supplementation could have similar effects on lumbar BMD as 1.000 mg of calcium carbonate. These findings may indicate that lactulose may improve calcium absorption in postmenopausal women. A long follow-up study with a greater number of subjects would be necessary to confirm these preliminary observations.

Low-Dose Lactulose as a Prebiotic for Improved Gut Health and Enhanced Mineral Absorption

“…Differences in least-square means of BMD (measured in the lumbar spine) between lactulose and PBO at final visit were not statistically significant. The results suggest that lactulose may help to maintain BMD in postmenopausal women by increasing Ca absorption (68).…”

“…The chronic effect of lactulose use on maintenance of bone mineral density (BMD) has also been assessed in postmenopausal women with osteopenia (68). In a randomized, double-blind, PBO-controlled parallel-group study, 41 women received either lactulose 10 g, vitamin D3 400 IU, and CaCO 3 500 mg, or PBO, vitamin D3 400 IU plus CaCO 3 1,000 mg once daily for 12 months.…”