TY - JOUR
T1 - Vitamin D Supplementation in Elderly Black Women Does Not Prevent Bone Loss
T2 - A Randomized Controlled Trial
AU - Aloia, John
AU - Fazzari, Melissa
AU - Islam, Shahidul
AU - Mikhail, Mageda
AU - Shieh, Albert
AU - Katumuluwa, Subhashini
AU - Dhaliwal, Ruban
AU - Stolberg, Alexandra
AU - Usera, Gianina
AU - Ragolia, Louis
N1 - Funding Information:
This work was supported by grants from the National Institute of Health (NIH) and Office of Dietary Supplements (ODS); R01-AG032440-01A2. DSMB Committee Members: Munro Peacock, MD, DSc; Bess Dawson-Hughes, MD; Lynette Smith, MS; Judy Hannah, PhD; Rebecca Costello, PhD; Christopher Sempos, PhD; Andy Hoofnagle MD, PhD, Director, Nutrition and Obesity Research Center, University of Washington. We thank Sharon Sprintz for her expertise as a dual-energy X-ray absorptiometry technician, and Jane Greensher for her expertise as the Nurse Coordinator.
Funding Information:
This work was supported by grants from the National Institute of Health (NIH) and Office of Dietary Supplements (ODS); R01-AG032440-01A2. DSMB Committee Members: Munro Peacock, MD, DSc; Bess Dawson-Hughes, MD; Lynette Smith, MS; Judy Hannah, PhD; Rebecca Costello, PhD; Christopher Sempos, PhD; Andy Hoofnagle MD, PhD, Director, Nutrition and Obesity Research Center, University of Washington. We thank Sharon Sprintz for her expertise as a dual-energy X-ray absorptiometry technician, and Jane Greensher for her expertise as the Nurse Coordinator. Authors? roles: JFA designed and supervised and wrote the manuscript; MM was responsible for medical supervision of the study participants. JFA designed the study; SI and MF, the study statisticians, were responsible for the data and statistical analyses and contributed to the writing of the manuscript. AS, SK, RD, AS, and GU were research fellows who were responsible for clinical care, data gathering, data presentation, and analysis and review of the manuscript. LR, the laboratory director, was responsible for the biochemical assays. None of the authors had a personal or financial conflict of interest.
Publisher Copyright:
© 2018 American Society for Bone and Mineral Research
PY - 2018/11
Y1 - 2018/11
N2 - Black Americans have lower levels of serum 25(OH)D but superior bone health compared to white Americans. There is controversy over whether they should be screened for vitamin D deficiency and have higher vitamin D requirements than recommended by the Institute of Medicine (IOM). The purpose of this trial was to determine whether Vitamin D supplementation in elderly black women prevents bone loss. A total of 260 healthy black American women, 60 years of age and older were recruited to take part in a two-arm, double-dummy 3-year randomized controlled trial (RCT) of vitamin D3 versus placebo. The study was conducted in an ambulatory clinical research center. Vitamin D3 dose was adjusted to maintain serum 25(OH)D above 75 nmol/L. Bone mineral density (BMD) and serum were measured for parathyroid hormone (PTH), C-terminal crosslink telopeptide (CTX), and bone-specific alkaline phosphatase (BSAP) every 6 months. Baseline serum 25(OH)D3 was 54.8 ± 16.8 nmol/L. There was no group × time interaction effect for any BMD measurement. For all BMD measurements, except for total body and spine, there was a statistically significant negative effect of time (p < 0.001). An equivalency analysis showed that the treatment group was equivalent to the control group. Serum PTH and BSAP declined, with a greater decline of PTH in the treatment group. The rate of bone loss with serum 25(OH)D above 75 nmol/L is comparable to the rate of loss with serum 25(OH)D at the Recommended Dietary Allowance (RDA) of 50 nmol/L. Black Americans should have the same exposure to vitamin D as white Americans.
AB - Black Americans have lower levels of serum 25(OH)D but superior bone health compared to white Americans. There is controversy over whether they should be screened for vitamin D deficiency and have higher vitamin D requirements than recommended by the Institute of Medicine (IOM). The purpose of this trial was to determine whether Vitamin D supplementation in elderly black women prevents bone loss. A total of 260 healthy black American women, 60 years of age and older were recruited to take part in a two-arm, double-dummy 3-year randomized controlled trial (RCT) of vitamin D3 versus placebo. The study was conducted in an ambulatory clinical research center. Vitamin D3 dose was adjusted to maintain serum 25(OH)D above 75 nmol/L. Bone mineral density (BMD) and serum were measured for parathyroid hormone (PTH), C-terminal crosslink telopeptide (CTX), and bone-specific alkaline phosphatase (BSAP) every 6 months. Baseline serum 25(OH)D3 was 54.8 ± 16.8 nmol/L. There was no group × time interaction effect for any BMD measurement. For all BMD measurements, except for total body and spine, there was a statistically significant negative effect of time (p < 0.001). An equivalency analysis showed that the treatment group was equivalent to the control group. Serum PTH and BSAP declined, with a greater decline of PTH in the treatment group. The rate of bone loss with serum 25(OH)D above 75 nmol/L is comparable to the rate of loss with serum 25(OH)D at the Recommended Dietary Allowance (RDA) of 50 nmol/L. Black Americans should have the same exposure to vitamin D as white Americans.
KW - ANALYSIS/QUANTITATION OF BONE
KW - BIOCHEMICAL MARKERS OF BONE TURNOVER
KW - BONE MODELING AND REMODELING
KW - CELL/TISSUE SIGNALING
KW - CLINICAL TRIALS
KW - DISEASES AND DISORDERS OF/RELATED TO BONE
KW - DXA
KW - ENDOCRINE PATHWAYS
KW - OSTEOPOROSIS
KW - PTH/VIT D/FGF23
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U2 - 10.1002/jbmr.3521
DO - 10.1002/jbmr.3521
M3 - Article
C2 - 29905969
AN - SCOPUS:85050600277
SN - 0884-0431
VL - 33
SP - 1916
EP - 1922
JO - Journal of Bone and Mineral Research
JF - Journal of Bone and Mineral Research
IS - 11
ER -
