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 — OTHER
    A 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_SUPPLEMENT
    A 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 Food
    Participants 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 Supplement
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical and Translational Science Center, Weill Cornell Medical CollegeNew YorkNew York10065

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