Urinary tract stone occurrence in the Women’s Health Initiative (WHI) randomized clinical trial of calcium and vitamin D supplements

Wallace, Robert B.; Wactawski‐Wende, Jean; OʼSullivan, Mary J.; Larson, Joseph C.; Cochrane, Barbara B.; Gass, Margery; Masaki, Kamal

doi:10.3945/ajcn.110.003350

Cited by 138 publications

(77 citation statements)

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“…In women receiving 1 g calcium plus 10 µg vitamin D daily for a mean of seven years, a higher incidence of self-reported urinary tract stones was reported compared to those receiving placebo (Wallace et al, 2011). Plasma or serum 25(OH)D concentrations were not measured in this study.…”

Section: Vitamin D Intake or Status And Long-term Health Outcomes In mentioning

confidence: 52%

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2012

EFSA Journal

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Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to re-evaluate the safety in use of vitamin D and to provide, if necessary, revised Tolerable Upper Intake Levels (ULs) of vitamin D for all relevant population groups. The ULs for adults including pregnant and lactating women, children and adolescents were revised. For adults, hypercalcaemia was selected as the indicator of toxicity. In two studies in men, intakes between 234 and 275 µg/day were not associated with hypercalcaemia, and a no observed adverse effect level (NOAEL) of 250 µg/day was established. Taking into account uncertainties associated with these studies, the UL for adults including pregnant and lactating women was set at 100 µg/day. Despite a continuing paucity of data for high vitamin D intakes in children and adolescents, the UL was adapted to 100 µg/day for ages 11-17 years, considering that owing to phases of rapid bone formation and growth this age group is unlikely to have a lower tolerance for vitamin D compared to adults. The same applies also to children aged 1-10 years, but taking into account their smaller body size, a UL of 50 µg/day is proposed. For infants, the UL of 25 µg/day based on previously available data relating high vitamin D intakes to impaired growth and hypercalcaemia was retained as limited additional evidence has emerged since the previous risk assessment. Data Hypercalciuria can be associated with hypercalcaemia, but it can also occur without.For the derivation of the UL, the occurrence of hypercalcaemia and hypercalciuria has been assessed in studies using daily or weekly supplementation of vitamin D for several weeks to months. The shorter-term studies were generally performed in seasons of low sun exposure. Study populations were not generally vitamin D-deficient, and two studies were conducted in subjects with a high vitamin D status at baseline. Study populations included whites, African Americans, young men, preand postmenopausal women, elderly nursing home residents, and overweight and obese adults. It was concluded that vitamin D at doses up to 275 µg/day does not lead to persisting hypercalcaemia or hypercalciuria in adults.Long-term health outcomes (all-cause mortality, cardiovascular disease, cancer, fractures and kidney stones) were also considered, but no studies reported an association between vitamin D intake and increased risk for adverse long-term health outcomes. Studies reporting on an association between 25(OH)D concentration and all-cause mortality or cancer were inconsistent. When 25(OH)D concentrations were associated with an increased risk for adverse long-term health outcomes in some studies, there was a wide variation in 25(OH)D concentrations associated with the adverse effect. It was considered that 25(OH)D concentrations cannot be used to characterise the risk for adverse long-term health outcomes.In adults, a daily vitamin D dose of 250 µg/day (range 234-275 µg/day) was considered to reflect a no observed adverse...

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Section: Vitamin D Intake or Status And Long-term Health Outcomes In mentioning

confidence: 52%

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2012

EFSA Journal

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“…Because of the known risk of kidney stones with calcium supplement intake above 1500 mg [1,4,5] and emerging concerns that calcium supplementation is associated with increased risk of myocardial infarction [12], excessive calcium intake is also a potential quality and safety concern.…”

Section: Discussionmentioning

confidence: 99%

Overuse and underuse of calcium and vitamin D in women with osteoporosis: A survey in a primary care setting

Silva¹,

Romeiser²,

Baker³

et al. 2013

OJPM

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Introduction: Optimal calcium and vitamin D intake is important components of the treatment of osteoporosis. The national average calcium and vitamin D intake for women over age 50 is below the recommended levels for optimal bone health. The aim of this study was to assess whether deficiencies in calcium and vitamin D intake exist in women with osteoporosis in a general medicine practice, as well as evaluate whether physicians accurately document calcium and vitamin D supplementation in the health record. Methods: Using the Electronic Health Record (EHR), we identified all female patients age 50 and older with the diagnosis of osteoporosis who were seen at the study site clinic, an urban academic general medicine practice, between January 1 st , 2010 and December 1 st , 2010. Women were randomly selected to receive an invitation to participate in a telephone survey on osteoporosis treatment. Results: One hundred and sixteen women completed the telephone survey. The mean calcium intake was 1524 mg per day. Forty-nine percent of women surveyed reported taking less than 1200 mg/day of supplemental calcium. When considering reported calcium intake from diet, 33% percent consumed less than 1200 mg/day and 52% percent consumed more than 1500 mg/day. Twenty eight percent of patients were taking less than 800 IU/day of vitamin D; only four percent were taking more than 4000 IU/day. Agreement between patients' self-reported intake of calcium, vitamin D and multivitamin supplements and physicians' documentation of these supplements was 52% for calcium, 53% for vitamin D and 61% for multivitamin. Conclusion: Among women with osteoporosis getting regular care in a general medicine practice, approximately a third are getting less than the recommended daily amount of calcium and a quarter less than the recommended amount of vitamin D. In addition, a significant proportion of women are getting excessive daily amounts of calcium, which may also be a quality concern. Rates of agreement between self-reported calcium and vitamin D supplements and chart documentation of these supplements were low.

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“…(2) In addition to mild and often self-limited gastrointestinal intolerance, the most important confirmed side effect of supplementation is a 17% increase in nephrolithiasis. (3) The calcium supplement landscape, however, has changed considerably since the publication of two meta-analyses by Bolland and colleagues in 2010 (4) and 2011, (5) concluding that calcium supplements increase the risk of both coronary and cerebrovascular events. The first meta-analysis pooled 15 placebo-controlled trials of calcium supplements without vitamin D and found a statistically significant 31% increased risk of myocardial infarction (p ¼ 0.04) and a nonsignificant 20% increased risk of stroke (p ¼ 0.11) among calcium-treated individuals.…”

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confidence: 99%

The Calcium Supplement Controversy: Now What?

Bauer

2014

Journal of Bone and Mineral Research

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F or decades there has been a consistent public health message about the use of calcium supplements in healthy adults: they prevent fracture and have no serious side effects. Although there is disagreement about the populations that are most likely to benefit and the magnitude of antifracture benefits, the best evidence pooled from multiple placebo-controlled trials suggests that supplementation with calcium plus vitamin D reduces fracture risk about 12%. (1) Some populations, such as the institutionalized elderly and those with inadequate dietary intake, may benefit from supplements to a greater degree than independent-living individuals with adequate calcium intake. The potential nonskeletal benefits of calcium supplementation remain controversial. (2) In addition to mild and often self-limited gastrointestinal intolerance, the most important confirmed side effect of supplementation is a 17% increase in nephrolithiasis. (3) The calcium supplement landscape, however, has changed considerably since the publication of two meta-analyses by Bolland and colleagues in 2010 (4) and 2011, (5) concluding that calcium supplements increase the risk of both coronary and cerebrovascular events. The first meta-analysis pooled 15 placebo-controlled trials of calcium supplements without vitamin D and found a statistically significant 31% increased risk of myocardial infarction (p ¼ 0.04) and a nonsignificant 20% increased risk of stroke (p ¼ 0.11) among calcium-treated individuals. (4) The study received considerable attention in the lay press, but was also criticized for excluding calcium plus vitamin D trials, inconsistent validation of cardiovascular endpoints, and the lack of a dose-response. In fact, analyses stratified on baseline calcium intake revealed significant supplement-related increases in myocardial infarction among those with higher pretreatment dietary calcium intake (above the median of 805 mg/d) but not among those with lower pretreatment calcium intake (interaction p ¼ 0.01).A follow-up meta-analysis by Bolland and colleagues 5 addressed at least some of these criticisms by including calcium plus vitamin D trials, and the results were similar: after pooling eight placebo-controlled trials, randomization to calcium alone or calcium plus vitamin D was associated with a statistically significant 24% increase in myocardial infarction (p ¼ 0.004) and a nonsignificant 15% increase in stroke (p ¼ 0.06). Although Bolland and colleagues included the Women's Health Initiative (WHI) Calcium Plus Vitamin D Supplementation Trial, which rigorously adjudicated thousands of cardiovascular outcomes and had previously reported no increase in vascular events among the calcium plus D group, (6) in their second meta-analysis Bolland and colleagues (5) excluded the 46% of WHI participants taking personal calcium supplements at baseline. The rationale offered for excluding women taking personal calcium supplements was that it allowed a pure comparison of supplement use versus no supplement use. Unfortunately, analysis of a subset...

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Urinary tract stone occurrence in the Women’s Health Initiative (WHI) randomized clinical trial of calcium and vitamin D supplements

Abstract: Daily supplementation with CaD for 7 y was associated with an increase in the number of self-reported urinary tract stones. These findings have implications for CaD supplement use. This trial was registered with the WHI at clinicaltrials.gov as NCT00000611.

Cited by 138 publications

References 36 publications

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Overuse and underuse of calcium and vitamin D in women with osteoporosis: A survey in a primary care setting

The Calcium Supplement Controversy: Now What?

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