Brunner Robert L, Cochrane Barbara, Jackson Rebecca D, Larson Joseph, Lewis Cora, Limacher Marian, Rosal Milagros, Shumaker Sally, Wallace Robert
University of Nevada School of Medicine, PMB 251, MS 145, Reno, NV 89557, USA.
J Am Diet Assoc. 2008 Sep;108(9):1472-9. doi: 10.1016/j.jada.2008.06.432.
The Women's Health Initiative (WHI) randomized trial of calcium/vitamin D supplementation found reduced bone loss with active treatment compared to placebo. Now we examine whether the treatment affected self-reported physical functioning and objective measures of physical functioning.
A randomized, double-blind, placebo-controlled trial of 1,000 mg calcium carbonate plus 400 IU vitamin D(3) per day or matching placebo pills.
SUBJECTS/SETTING: The study included 33,067 women (50 to 79 years old) at 40 US study centers.
Physical functioning was assessed by questionnaire at enrollment in WHI, 1 year prior to calcium/vitamin D trial randomization and at study close-out (average follow-up 7.1 years). Objective physical performance and self-reported exercise measures were collected at WHI baseline (1 year prior to calcium/vitamin D enrollment) and 2 years and 4 years after calcium/vitamin D trial enrollment in a subsample (n=3,137).
Calcium/vitamin D effects were tested in unadjusted and interaction linear models for each of the physical function measures. Covariates were baseline total calcium intake, fracture risk score, treatment arm in the hormone therapy and dietary modification trials (ie, active drug or placebo, low-fat diet intervention or usual diet, respectively) and age.
Neither intention to treat nor high adherence analyses produced substantial effects of calcium/vitamin D compared to placebo on physical functioning or performance. The interaction analyses also did not result in differences because of calcium/vitamin D.
As the first long-term randomized trial to examine the effectiveness of calcium and vitamin D in protecting against decline of physical functioning in older women, the results did not support benefit.
女性健康倡议（WHI）关于补充钙/维生素D的随机试验发现，与安慰剂相比，积极治疗可减少骨质流失。现在我们研究该治疗是否影响自我报告的身体功能和身体功能的客观指标。
一项随机、双盲、安慰剂对照试验，每日服用1000毫克碳酸钙加400国际单位维生素D（3）或匹配的安慰剂药丸。
受试者/地点：该研究纳入了美国40个研究中心的33067名女性（50至79岁）。
在WHI研究入组时、钙/维生素D试验随机分组前1年以及研究结束时（平均随访7.1年），通过问卷调查评估身体功能。在WHI基线（钙/维生素D入组前1年）以及钙/维生素D试验入组后2年和4年，对一个子样本（n = 3137）收集客观身体表现和自我报告的运动指标。
针对每项身体功能指标，在未调整和交互线性模型中测试钙/维生素D的效果。协变量包括基线总钙摄入量、骨折风险评分、激素治疗和饮食调整试验中的治疗组（即分别为活性药物或安慰剂、低脂饮食干预或常规饮食）以及年龄。
与安慰剂相比，无论是意向性分析还是高依从性分析，钙/维生素D对身体功能或表现均未产生显著影响。交互分析也未因钙/维生素D而产生差异。
作为首个研究钙和维生素D预防老年女性身体功能下降有效性的长期随机试验，结果不支持其有益作用。
