Health TrialsbyHealthPanel

Calcium-Rich Food Versus Calcium Carbonate for Bone Health

ConditionsOsteopeniaOsteoporosisBone Health in Perimenopausal WomenMenopause Related ConditionsFracture Healing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-90
SponsorCornell University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 500 mg calcium from milk-derived minerals

    Other intervention

    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.

Treatment groups

217 Participants
are divided into 2 treatment groups
Group A: Calcium-Rich FoodExperimental treatment 1 intervention
Group B: Calcium Carbonate SupplementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Continuous Adherence to Assigned Calcium Intervention

Measuring adherence to calcium intake

Time frame
4 weeks

Secondary outcomes

1

Gastrointestinal Symptom Rating Scale (GSRS) Score

Gastrointestinal tolerability will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS). Scores will be compared between study groups.

Time frame
4 weeks

Other outcomes

1

Treatment Satisfaction

Treatment satisfaction will be assessed using Questions 9, 10, and 14 of the Treatment Satisfaction Questionnaire for Medication (TSQM).

Time frame
4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cornell University

Lead sponsor

Weill Medical College of Cornell University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: