Calcium- and Vitamin D3-Fortified Milk Reduces Bone Loss at Clinically Relevant Skeletal Sites in Older Men: A 2-Year Randomized Controlled Trial

Abstract

In this 2-year randomized controlled study of 167 men >50 years of age, supplementation with calcium-vitamin D 3 -fortified milk providing an additional 1000 mg of calcium and 800 IU of vitamin D 3 per day was effective for suppressing PTH and stopping or slowing bone loss at several clinically important skeletal sites at risk for fracture.Introduction: Low dietary calcium and inadequate vitamin D stores have long been implicated in age-related bone loss and osteoporosis. The aim of this study was to assess the effects of calcium and vitamin D 3 fortified milk on BMD in community living men >50 years of age. Materials and Methods:This was a 2-year randomized controlled study in which 167 men (mean age ± SD, 61.9 ± 7.7 years) were assigned to receive either 400 ml/day of reduced fat (∼1%) ultra-high temperature (UHT) milk containing 1000 mg of calcium plus 800 IU of vitamin D 3 or to a control group receiving no additional milk. Primary endpoints were changes in BMD, serum 25(OH)D, and PTH. Results: One hundred forty-nine men completed the study. Baseline characteristics between the groups were not different; mean dietary calcium and serum 25(OH)D levels were 941 ± 387 mg/day and 77 ± 23 nM, respectively. After 2 years, the mean percent change in BMD was 0.9-1.6% less in the milk supplementation compared with control group at the femoral neck, total hip, and ultradistal radius (range, p < 0.08 to p < 0.001 after adjusting for covariates). There was a greater increase in lumbar spine BMD in the milk supplementation group after 12 and 18 months (0.8-1.0%, p Յ 0.05), but the between-group difference was not significant after 2 years (0.7%; 95% CI, −0.3, 1.7). Serum 25(OH)D increased and PTH decreased in the milk supplementation relative to control group after the first year (31% and −18%, respectively; both p < 0.001), and these differences remained after 2 years. Body weight remained unchanged in both groups at the completion of the study. Conclusions: Supplementing the diet of men >50 years of age with reduced-fat calcium-and vitamin D 3 -enriched milk may represent a simple, nutritionally sound and cost-effective strategy to reduce age-related bone loss at several skeletal sites at risk for fracture in the elderly.

Long-term effect of calcium-vitamin D3 fortified milk on blood pressure and serum lipid concentrations in healthy older men

“…Of the 167 men, 18 withdrew from the study (9 milk, 9 control), yielding a dropout rate of 10.8% (Daly et al, 2006b). The reasons for withdrawal have been described previously (Daly et al, 2006b).…”

“…As described previously (Daly et al, 2006b), communityliving Caucasian men aged 450 years were recruited into this study from residential areas of Melbourne, Australia. Participants were initially excluded if they had taken calcium-vitamin D supplements in the preceding 12 months, participated in regular resistance training in the previous 6 months or greater than 150 min per week of weight-bearing exercise, had a body mass index (BMI) 435 kg/m 2 , were lactose intolerant, consumed more than four alcoholic beverages per day or had a history of osteoporotic fracture or medical disease or medication use known to affect bone metabolism.…”

“…Of the 167 men, 18 withdrew from the study (9 milk, 9 control), yielding a dropout rate of 10.8% (Daly et al, 2006b). The reasons for withdrawal have been described previously (Daly et al, 2006b). For this study, participants on lipidlowering (n ¼ 32) or antihypertensive medication (n ¼ 39) were included, but those who commenced (n ¼ 16), increased (n ¼ 6) or decreased (n ¼ 5) their number of lipidlowering or antihypertensive drugs throughout the intervention were excluded.…”

“…The vitamin D 3 used to fortify the milk was obtained from DSM Nutritional Products Pty Ltd (NSW, Australia). As previously reported (Daly et al, 2006b), eight batches of milk were manufactured throughout the study, with participants receiving a new batch every 3 months. The quality of each batch was analyzed in terms of the calcium and vitamin D 3 level before being distributed.…”

Efficacy of food fortification for the prevention of vitamin D deficiency – results of a systematic review and meta-analysis

“…Dose, latitude and baseline 25(OH)D were identified a priori as probable sources of heterogeneity. Fourteen trials were included (n 936; 483 treated and 453 controls), derived from eleven published studies (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11) , all of which showed a statistically significant beneficial effect of food fortification on circulating 25(OH)D concentrations. Individual treatment effects ranged from 10.00 (95% 23.20) to 36.25 (22.47, 50.03) nmol/l.…”