Urinary tract stone occurrence in the Women's Health Initiative (WHI) randomized clinical trial of calcium and vitamin D supplements
Wallace RB, Wactawski-Wende J, O'Sullivan MJ, Larson JC, Cochrane B, Gass M, Masaki K
The American journal of clinical nutrition · 93 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Institutes of Health
- Gobierno
- WHI NIH HHS
- Subvenciones
- National Institutes of Health (N01 WH 44221); National Institutes of Health (N01-WH-3-2115); National Institutes of Health (N01WH24152); National Institutes of Health (N01-WH-3-2122); National Institutes of Health (N01-WH-2-2110); National Institutes of Health (N01WH42129-32); National Institutes of Health (N01-WH-32108-9); National Institutes of Health (N01WH 32111-13); National Institutes of Health (N01 WH 32105-6); National Institutes of Health (N01-WH-32100-2); National Institutes of Health (N01-WH-42107-26); National Institutes of Health (N01WH 32118-32119)
Según 2 financiadores declarados.
Publicación
- Publicado
- 2011-04-28 · Am J Clin Nutr · vol. 94 · número 1 · págs. 270–277
- Editorial
- Elsevier BV
- Citado
- 164 citas · más que el 99% de estudios similares · 13.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 38 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Kidney Stones and Urolithiasis Treatments · Vitamin D Research Studies · Bone health and osteoporosis research
- Palabras clave
- urolithiasis, calcium and vitamin D supplementation, Women's Health Initiative, postmenopausal women, stone incidence, risk factors, calcium intake, supplement adherence, kidney stones
- MeSH
- humans, urinary calculi, calcium, dietary, vitamin d, risk factors, dietary supplements, aged, middle aged, women's health, female
7 autores
- Robert B. Wallace🇺🇸 · autor de correspondenciaUniversity of Hawaiʻi at Mānoa; University of Iowa; University of Miami; University of Washington; Fred Hutch Cancer Center; University of Cincinnati; University at Buffalo, State University of New York
- Jean Wactawski‐Wende🇺🇸University of Hawaiʻi at Mānoa; University of Iowa; University of Miami; University of Washington; Fred Hutch Cancer Center; University of Cincinnati; University at Buffalo, State University of New York
- Mary Jo O’Sullivan🇺🇸University of Hawaiʻi at Mānoa; University of Iowa; University of Miami; University of Washington; Fred Hutch Cancer Center; University of Cincinnati; University at Buffalo, State University of New York
- Joseph C. Larson🇺🇸University of Hawaiʻi at Mānoa; University of Iowa; University of Miami; University of Washington; Fred Hutch Cancer Center; University of Cincinnati; University at Buffalo, State University of New York
- Barbara B. Cochrane🇺🇸University of Hawaiʻi at Mānoa; University of Iowa; University of Miami; University of Washington; Fred Hutch Cancer Center; University of Cincinnati; University at Buffalo, State University of New York
- Margery L S Gass🇺🇸University of Hawaiʻi at Mānoa; University of Iowa; University of Miami; University of Washington; Fred Hutch Cancer Center; University of Cincinnati; University at Buffalo, State University of New York
- Kamal Masaki🇺🇸University of Hawaiʻi at Mānoa; University of Iowa; University of Miami; University of Washington; Fred Hutch Cancer Center; University of Cincinnati; University at Buffalo, State University of New York
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
The Women's Health Initiative (WHI) randomized clinical trial (RCT) of calcium plus vitamin D (CaD) supplements found a 17% excess in urinary tract stone incidence in the supplemented group. This study evaluated whether this risk is modified by participant characteristics.
Objective
We examined the correlates of urinary tract stone occurrence in the CaD arm of the WHI trial.
Design
We analyzed an RCT involving 36,282 postmenopausal women aged 50-79 y from 40 WHI centers: 18,176 women received 500 mg calcium carbonate plus 200 IU vitamin D(3) twice daily (1000 mg and 400 IU daily, respectively), and 18,106 women received a matching placebo for an average of 7.0 y. The incidence of urinary tract stones was determined.
Results
The incidence of self-reported clinically diagnosed urinary tract stones was more common in the active CaD medication group than in the placebo group (hazard ratio: 1.17; 95% CI: 1.02, 1.34): 449 women in the CaD group and 381 women in the placebo group reported a stone during the trial. The rates of self-reported stones did not differ between various demographic, anthropomorphic, dietary, and other hypothesized risk factors according to randomization assignment. Neither the total calcium intake nor the use of calcium supplements at baseline was associated with the risk of stones. In sensitivity analyses that censored participants who were below 80% adherence, the findings were similar.
Conclusions
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.
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