Trials / Unknown
UnknownNCT05381168
Calcium From Fish Bone in Volunteers With Osteopenia
Efficacy and Safety of Calcium From Fish Bone in Volunteers With Osteopenia
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Chulalongkorn University · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
Summary
The aims of this study are to explore efficacy and safety of calcium from fish bone in volunteers with osteopenia. The volunteers are divided into 2 groups which are calcium from fish bone treatment group and calcium carbonate treatment group. Both groups received the calciums everyday for 6 months. Bone mineral density, blood examination, physical examination, adverse events, and satisfaction are evaluated before and after treatment.
Detailed description
The aims of this study are to explore efficacy and safety of calcium from fish bone in volunteers with osteopenia. The volunteers are divided into 2 groups which are calcium from fish bone treatment group and calcium carbonate treatment group. Both groups received the calciums everyday for 6 months. Bone mineral density is analyzed before and after treatment. Osteocalcin, total procollagen type-1 N-terminal propeptide (P1NP), beta-crosslaps, parathyroid hormone (PTH), calcium, phosphate level, vitamin D level (Serum 25(OH)D), albumin, aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), creatinine (Cr), blood urea nitrogen (BUN), and complete blood count (CBC) are assessed before and after taking for 3 and 6 months. Physical performance and food diary are also tested and records. Moreover, adverse effects including skin allergy, gastrointestinal abnormality, respiratory abnormality are evaluated. Satisfaction is asked after treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Calcium from fish bone | Calcium from fish bone contained calcium 312 mg and vitamin D 100 IU per capsule. |
| DIETARY_SUPPLEMENT | Calcium carbonate | Calcium carbonate contained calcium 600 mg and vitamin D 200 IU per capsule. |
Timeline
- Start date
- 2022-05-20
- Primary completion
- 2022-11-30
- Completion
- 2022-12-31
- First posted
- 2022-05-19
- Last updated
- 2022-05-19
Source: ClinicalTrials.gov record NCT05381168. Inclusion in this directory is not an endorsement.