Evaluating Adherence, Tolerability, and Safety of a Novel Oral Dietary Calcium Chew vs. Calcium Carbonate in Women 40-90: A Real-Life, Prospective, Randomized Controlled Trial
Cornell University
Summary
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
Description
Calcium intake is an important component of bone health and osteoporosis prevention. Despite widespread recommendations for calcium supplementation, long-term adherence to traditional calcium supplements is often poor because of gastrointestinal side effects, difficulty swallowing tablets, and dissatisfaction with conventional formulations. This study is designed to compare adherence, tolerability, safety, and treatment satisfaction between a calcium-rich food and a traditional calcium carbonate supplement in women at increased risk for osteoporosis. Participants will be randomized in a 1:1 r…
Eligibility
- Age range
- 40–90 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria Female at birth, 40 to 90 years of age Family history of osteoporosis or history of fracture Willing and able to provide written informed consent Willing to comply with all study procedures Willing to refrain from making major dietary changes during the 4-week study No known allergy or intolerance to any study product ingredients Exclusion Criteria Medical condition that would interfere with study participation or adherence (including selected oncologic or psychiatric disorders) Known severe allergic reaction requiring an epinephrine auto-injector Pregnant, breastfeeding, or…
Interventions
- Other500 mg calcium from milk-derived minerals
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.
- Dietary SupplementCalcium Carbonate 500 MG
A commercially available calcium carbonate supplement providing 500 mg calcium, taken once daily with food for four weeks.
Location
- Clinical and Translational Science Center, Weill Cornell Medical CollegeNew York, New York