Shapses 2007.
| Trial name or title | The effect of vitamin D supplementation during caloric restriction on intestinal calcium absorption |
| Methods | Randomised, double‐blind, placebo‐controlled trial using parallel‐group design (two intervention groups) |
| Participants | Country: United Kingdom Estimated number of participants: 60 Inclusion criteria: postmenopausal women aged 50 to 70 years who are more than two years since last menses; obese or overweight; living in the geographic vicinity of Rutgers University Exclusion criteria: currently taking any medication known to influence calcium or bone metabolism, including hormone replacement therapy, or with evidence of diseases known to influence calcium metabolism (i.e. metabolic bone disease), hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, or renal disease, significant cardiac disease (i.e. heart attack or stroke in the past six months, abnormal electrocardiogram), active malignancy or cancer therapy within the past year; history of kidney stones; weight gain or weight loss (5% of body weight) within three months before recruitment; participation in other investigational studies during the 12‐month trial period; travel for longer than two consecutive weeks during the trial period; usually have a very high or low intake of calcium (more than 1500 mg or less than 500 mg per day) |
| Interventions | Paraticipants will be randomly assigned to receive: Intervention group 1: vitamin D3 (1200 IU) daily plus weight loss; Intervention group 2: (control group): placebo daily plus weight loss; Intervention group 3: vitamin D3 (1200 IU) daily plus weight maintenance; or Intervention group 4 (control group): vitamin D3 (1200 IU) daily plus weight maintenance for a period of five weeks |
| Outcomes | Primary outcome measure will be changes in calcium absorption. Secondary outcome measures will be changes in serum and urine bone markers, hormones, proteins and genes |
| Starting date | March 2007; Expected completion: May 2011 |
| Contact information | Sue Shapses, PhD, RD; shapses@aesop.rutgers.edu |
| Notes |