Conditions: Calcium Deficiency Vitamin D Deficiency
Keywords: Drug therapy Increase in calcium urinary excretion and PTH decrease in serum
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 55
Healthy volunteers: yes

Brief summary:
The purpose of this study is to demonstrate that the intestinal absorption of calcium from a newly developed calcium carbonate-vitamin D3 chewable tablet formulation increases the amount of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as compared to baseline.

Detailed description:
The drug being tested in this study is called Calcichew. This study will look at calcium absorption in healthy postmenopausal women and healthy men.

The study will enroll approximately 55 healthy adults. All participants will receive Calcichew.

All participants will be asked to take one chewable tablet at the same time each day for three days in period 2 of the trial.

This trial will be conducted at one clinical site in Germany. The overall time to participate in this study is 4 weeks. Participants will make 9 visits to the clinic, and will be contacted by telephone 7days after last dose of study drug for a follow-up assessment.

Arms:
arm 1: Period 1: Low calcium meals for up to 3 days.

Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals.

Interventions: intervention 1: Calcium 500 mg and Vitamin D3 800 IU intervention 2: Low calcium meals
Intervention descriptions: intervention 1: Calcium 500 mg and Vitamin D3 800 IU chewable tablets intervention 2: A normal Western European diet with reduced calcium content (400 mg per day).

Protocol document: