Calcium-Rich Food Versus Calcium Carbonate for Bone Health
Part of paid clinical trials in New York, New York.
- Sponsor
- Cornell University
- Study ID
- NCT07763509
- Status
- Not Yet Recruiting
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Conditions
- Bone Health in Perimenopausal Women
- Fracture Healing
- Menopause Related Conditions
- Osteopenia
- Osteoporosis
Eligibility Criteria
- Sex
- FEMALE
- Age
- 40 Years - 90 Years
- Healthy Volunteers
- Accepted
Interventions
- 500 mg calcium from milk-derived minerals — OTHERA calcium-rich food providing 500 mg of calcium from milk-derived minerals, consumed once daily for four weeks. The product also contains dates, milk protein concentrate, almonds, vitamin D from mushrooms, and white button mushrooms. Participants consume one serving daily with or without food. The product is supplied in unbranded packaging.
- Calcium Carbonate 500 MG — DIETARY_SUPPLEMENTA commercially available calcium carbonate supplement providing 500 mg calcium, taken once daily with food for four weeks.
Study Details
This study will compare adherence, tolerability, safety, and treatment satisfaction between a calcium-rich food and a traditional calcium carbonate supplement in women ages 40 to 90 who are at increased risk for osteoporosis. Participants will be randomly assigned to receive either a calcium-rich food providing 500 mg of calcium from milk-derived minerals or a 500 mg calcium carbonate supplement once daily for four weeks. Participants will complete brief weekly questionnaires assessing supplement use, gastrointestinal symptoms, and treatment satisfaction. The goal of the study is to determine whether the form in which calcium is consumed influences adherence and participant experience. No blood draws, imaging studies, or other invasive procedures are involved
Key Dates
- First listed
- Aug 13, 2026
- Start date
- Sep 1, 2026
- Status verified
- Aug 2026
- Primary completion
- Jun 1, 2027
- Completion
- Oct 1, 2027
Study Design
- Enrollment
- 217 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Calcium-Rich FoodParticipants assigned to this arm will consume one calcium-rich food providing 500 mg of calcium from milk-derived minerals once daily for four weeks. The product will be supplied in unbranded packaging. Participants will complete baseline and weekly questionnaires assessing adherence, gastrointestinal tolerability, treatment satisfaction, and safety.
- Active Comparator: Calcium Carbonate SupplementParticipants assigned to this arm will consume one 500 mg calcium carbonate supplement once daily with food for four weeks. Participants will complete baseline and weekly questionnaires assessing adherence, gastrointestinal tolerability, treatment satisfaction, and safety.
Primary Outcome Measure
Continuous Adherence to Assigned Calcium Intervention [ Time Frame: 4 weeks ]
Central Contacts
- Adrienne Bitar, PhD4154255198
- Jennifer Han, PharmD925-389-8080
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Clinical and Translational Science Center, Weill Cornell Medical College | New York | New York | 10065 | Jeff Zhu |
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