Hypocalcemia; Dietary
Conditions
Brief summary
Interventional Clinical trial with food supplement, randomized, double-blind, comparative between microencapsulated calcium, calcium carbonate salts standardized and calcium citrate, in a population of postmenopausal women, lasting 1 month.
Interventions
DIETARY_SUPPLEMENTCalcium supplement
Calcium supplement for low contribution of elemental calcium in the daily diet
Sponsors
Nexentia S.A.S.
Instituto Palacios
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Women
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Postmenopausal woman * Low contribution of elemental calcium in the daily diet
Exclusion criteria
* Hypersensitivity to the active substances or to any of the excipients * Renal insufficiency * History of kidney or urinary stones * Use in the last month of diuretics (furosemide, ethacrynic acid), aluminum salts and / or thyroid hormones * Use of any other drug or experimental device during the 30 days prior to the selection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric symptoms | 1 month | Using the Gastrointestinal Symptom Rating Scale (GRS). The scale measures constipation, diarrhea, windiness, swelling, nausea, reflux, pain and burning. The patient will have to choose the most appropriate response among those proposed. Not at all is the better outcome and very strong discomfort is the worst outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in bone markers | Basal and 1 month | Bone Marker Analysis (CTx and P1NP) will be performed |
Countries
Spain
Outcome results
None listed