Erin S LeBlanc1, Haley Hedlin2, FeiFei Qin2, Manisha Desai2, Jean Wactawski-Wende3, Nancy Perrin4, JoAnn E Manson5, Karen C Johnson6, Kamal Masaki7, Frances A Tylavsky6, Marcia L Stefanick8. 1. Kaiser Permanente Center for Health Research, 3800 N. Interstate Ave., Portland, OR 97227, United States. Electronic address: erin.s.leblanc@kpchr.org. 2. Stanford University, Department of Medicine, 1070 Arastradero Rd., Palo Alto, CA 94304, United States. 3. University of Buffalo, 12 Capen Hall, Buffalo, NY 14260, United States. 4. Kaiser Permanente Center for Health Research, 3800 N. Interstate Ave., Portland, OR 97227, United States. 5. Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, 3rd floor, Boston, MA 02115, United States. 6. University of Tennessee Health Science Center, Department of Preventive Medicine, 66 N. Pauline, Suite 633, Memphis, TN 38163, United States. 7. University of Hawaii, 2500 Campus Road, Honolulu, HI 96822, United States. 8. Stanford University School of Medicine, Medical School Office Building, 1265 Welch Rd, Room X308, Mail code: 5411, Stanford, CA 94305-5411, United States.
Abstract
BACKGROUND: It is unknown whether supplementation with calcium and vitamin D has an impact on menopause-related symptoms. METHODS: As part of the Women's Health Initiative Calcium/Vitamin D Supplementation Trial (CaD), women were randomized at 40 clinical sites to elemental calciumcarbonate 1000 mg with vitamin D 400 IU daily or placebo. At the CaD baseline visit (year 1 or year 2) and during a mean follow-up of 5.7 years, participants provided data on menopause-related symptoms via questionnaires. Generalized linear mixed effects techniques were used to address research questions. RESULTS: After excluding participants with missing data (N=2125), we compared menopause-related symptoms at follow-up visits of 17,101 women randomized to CaD with those of 17,056 women given theplacebo. Women in the CaD arm did not have a different number of symptoms at follow-up compared to women taking the placebo (p=0.702). Similarly, there was no difference between sleep disturbance, emotional well-being, or energy/fatigue at follow-up in those who were randomized to CaD supplementation compared to those taking the placebo. CONCLUSIONS: Our data suggest that supplementation with 1000 mg of calcium plus 400 IU of vitamin D does not influence menopause-related symptoms over an average of 5.7 years of follow-up among postmenopausal women with an average age of 64 at the WHI baseline visit.
RCT Entities:
BACKGROUND: It is unknown whether supplementation with calcium and vitamin D has an impact on menopause-related symptoms. METHODS: As part of the Women's Health Initiative Calcium/Vitamin D Supplementation Trial (CaD), women were randomized at 40 clinical sites to elemental calcium carbonate 1000 mg with vitamin D 400 IU daily or placebo. At the CaD baseline visit (year 1 or year 2) and during a mean follow-up of 5.7 years, participants provided data on menopause-related symptoms via questionnaires. Generalized linear mixed effects techniques were used to address research questions. RESULTS: After excluding participants with missing data (N=2125), we compared menopause-related symptoms at follow-up visits of 17,101 women randomized to CaD with those of 17,056 women given the placebo. Women in the CaD arm did not have a different number of symptoms at follow-up compared to women taking the placebo (p=0.702). Similarly, there was no difference between sleep disturbance, emotional well-being, or energy/fatigue at follow-up in those who were randomized to CaD supplementation compared to those taking the placebo. CONCLUSIONS: Our data suggest that supplementation with 1000 mg of calcium plus 400 IU of vitamin D does not influence menopause-related symptoms over an average of 5.7 years of follow-up among postmenopausal women with an average age of 64 at the WHI baseline visit.
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