Calcium From Fish Bone in Volunteers With Osteopenia
Primary Purpose
Osteopenia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Calcium from fish bone
Calcium carbonate
Sponsored by
About this trial
This is an interventional prevention trial for Osteopenia focused on measuring osteopenia, calcium, fish bone, efficacy, safety
Eligibility Criteria
Inclusion Criteria:
- Male age more than 70 years or female age more than 65 years or all age volunteers that have at least 1 risk factors which are menopause before 45 years, menopause with the height reduction (more than 4 cm), body mass index less than 20 kg/mm2, bone fracture history, taking some medicine that has an effect on bone density reduction, have disease that has an effect on bone density reduction, Father and mother have bone fracture history, fracture risk assessment tool (FRAX) in intermediate risk, osteoporosis self-assessment tool for asian (OSTA) score, khon kaen osteoporosis study (KKOS) score in intermediate risk or higher intermediate risk
- Bone mineral density between -1 to -2.5
- No osteosclerosis
- Can read and write
- Willing to be volunteer
Exclusion Criteria:
- Allergic to calcium, magnesium, phosphorus, zinc, collagen, and osteocalcin
- Taking calcium or vitamin D with in 14 days before the study start
- Taking osteosclerosis' medicine
- Have uncontrolled diseases
- Pregnancy and lactation
- Participating in other study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Calcium from fish bone
Calcium carbonate
Arm Description
The volunteer will receive calcium from fish bone 4 capsules per day for 6 months.
The volunteer will receive calcium carbonate 2 tablets per day for 6 months.
Outcomes
Primary Outcome Measures
Bone mineral density score
Bone mineral density score is measured using dual energy x-ray absorptiometry scanner (DEXA scanner). It shows in term of T-score. The outcomes are compared bone mineral density score of calcium from fish bone group to calcium carbonate group.
Secondary Outcome Measures
Osteocalcin level
Changing of osteocalcin level of calcium from fish bone group compared to calcium carbonate group.
Total procollagen type-1 N-terminal propeptide (P1NP) level
Changing of P1NP level of calcium from fish bone group compared to calcium carbonate group.
Beta-crosslaps level
Changing of beta-crosslaps level of calcium from fish bone group compared to calcium carbonate group.
Parathyroid hormone (PTH) level
Changing of PTH level of calcium from fish bone group compared to calcium carbonate group.
Blood calcium level
Changing of blood calcium level of calcium from fish bone group compared to calcium carbonate group.
Blood phosphate level
Changing of blood phosphate level of calcium from fish bone group compared to calcium carbonate group.
Vitamin D level
Changing of vitamin D level of calcium from fish bone group compared to calcium carbonate group.
Liver function level
Changing of liver function level (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP)) of calcium from fish bone group compared to calcium carbonate group.
Creatinine level
Changing of creatinine (Cr) level of calcium from fish bone group compared to calcium carbonate group.
Blood urea nitrogen level
Changing of blood urea nitrogen (BUN) of calcium from fish bone group compared to calcium carbonate group.
Pain score
Changing of pain score using visual analogue scale (0 painless to 10 very pain) of calcium from fish bone group compared to calcium carbonate group.
Short physical performance battery score
Changing of short physical performance battery score (0 weak to 12 very strong)of calcium from fish bone group compared to calcium carbonate group.
Grip strength
Changing of grip strength (kilogram) of calcium from fish bone group compared to calcium carbonate group.
Skin allergic reactions
The outcome measurements of skin allergic reactions are appearance (have or no have) of rash, edema, bullae, pain, and itching.
Respiratory tract abnormality
The outcome measurements of respiratory tract abnormality are appearance (have or no have) of shortness of breath and asthma.
Gastrointestinal tract abnormality
The outcome measurements of gastrointestinal tract abnormality are appearance (have or no have) of nausea, vomiting, flatulence, constipation, and diarrhea.
Satisfaction level
Satisfaction score (0 unsatisfied to 10 very satisfied)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05381168
Brief Title
Calcium From Fish Bone in Volunteers With Osteopenia
Official Title
Efficacy and Safety of Calcium From Fish Bone in Volunteers With Osteopenia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 20, 2022 (Anticipated)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
Keywords
osteopenia, calcium, fish bone, efficacy, safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The volunteers are divided into 2 groups which are calcium from fish bone treatment group and calcium carbonate treatment group. Both groups receive the calciums every day for 6 months.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Calcium from fish bone
Arm Type
Experimental
Arm Description
The volunteer will receive calcium from fish bone 4 capsules per day for 6 months.
Arm Title
Calcium carbonate
Arm Type
Active Comparator
Arm Description
The volunteer will receive calcium carbonate 2 tablets per day for 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium from fish bone
Intervention Description
Calcium from fish bone contained calcium 312 mg and vitamin D 100 IU per capsule.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium carbonate
Intervention Description
Calcium carbonate contained calcium 600 mg and vitamin D 200 IU per capsule.
Primary Outcome Measure Information:
Title
Bone mineral density score
Description
Bone mineral density score is measured using dual energy x-ray absorptiometry scanner (DEXA scanner). It shows in term of T-score. The outcomes are compared bone mineral density score of calcium from fish bone group to calcium carbonate group.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Osteocalcin level
Description
Changing of osteocalcin level of calcium from fish bone group compared to calcium carbonate group.
Time Frame
6 months
Title
Total procollagen type-1 N-terminal propeptide (P1NP) level
Description
Changing of P1NP level of calcium from fish bone group compared to calcium carbonate group.
Time Frame
6 months
Title
Beta-crosslaps level
Description
Changing of beta-crosslaps level of calcium from fish bone group compared to calcium carbonate group.
Time Frame
6 months
Title
Parathyroid hormone (PTH) level
Description
Changing of PTH level of calcium from fish bone group compared to calcium carbonate group.
Time Frame
6 months
Title
Blood calcium level
Description
Changing of blood calcium level of calcium from fish bone group compared to calcium carbonate group.
Time Frame
6 months
Title
Blood phosphate level
Description
Changing of blood phosphate level of calcium from fish bone group compared to calcium carbonate group.
Time Frame
6 months
Title
Vitamin D level
Description
Changing of vitamin D level of calcium from fish bone group compared to calcium carbonate group.
Time Frame
6 months
Title
Liver function level
Description
Changing of liver function level (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP)) of calcium from fish bone group compared to calcium carbonate group.
Time Frame
6 months
Title
Creatinine level
Description
Changing of creatinine (Cr) level of calcium from fish bone group compared to calcium carbonate group.
Time Frame
6 months
Title
Blood urea nitrogen level
Description
Changing of blood urea nitrogen (BUN) of calcium from fish bone group compared to calcium carbonate group.
Time Frame
6 months
Title
Pain score
Description
Changing of pain score using visual analogue scale (0 painless to 10 very pain) of calcium from fish bone group compared to calcium carbonate group.
Time Frame
6 months
Title
Short physical performance battery score
Description
Changing of short physical performance battery score (0 weak to 12 very strong)of calcium from fish bone group compared to calcium carbonate group.
Time Frame
6 months
Title
Grip strength
Description
Changing of grip strength (kilogram) of calcium from fish bone group compared to calcium carbonate group.
Time Frame
6 months
Title
Skin allergic reactions
Description
The outcome measurements of skin allergic reactions are appearance (have or no have) of rash, edema, bullae, pain, and itching.
Time Frame
6 months
Title
Respiratory tract abnormality
Description
The outcome measurements of respiratory tract abnormality are appearance (have or no have) of shortness of breath and asthma.
Time Frame
6 months
Title
Gastrointestinal tract abnormality
Description
The outcome measurements of gastrointestinal tract abnormality are appearance (have or no have) of nausea, vomiting, flatulence, constipation, and diarrhea.
Time Frame
6 months
Title
Satisfaction level
Description
Satisfaction score (0 unsatisfied to 10 very satisfied)
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male age more than 70 years or female age more than 65 years or all age volunteers that have at least 1 risk factors which are menopause before 45 years, menopause with the height reduction (more than 4 cm), body mass index less than 20 kg/mm2, bone fracture history, taking some medicine that has an effect on bone density reduction, have disease that has an effect on bone density reduction, Father and mother have bone fracture history, fracture risk assessment tool (FRAX) in intermediate risk, osteoporosis self-assessment tool for asian (OSTA) score, khon kaen osteoporosis study (KKOS) score in intermediate risk or higher intermediate risk
Bone mineral density between -1 to -2.5
No osteosclerosis
Can read and write
Willing to be volunteer
Exclusion Criteria:
Allergic to calcium, magnesium, phosphorus, zinc, collagen, and osteocalcin
Taking calcium or vitamin D with in 14 days before the study start
Taking osteosclerosis' medicine
Have uncontrolled diseases
Pregnancy and lactation
Participating in other study
12. IPD Sharing Statement
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Calcium From Fish Bone in Volunteers With Osteopenia
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