OsteopeniaNCT05381168
Calcium From Fish Bone in Volunteers With Osteopenia
A study testing Calcium from fish bone and Calcium carbonate in people with Osteopenia, run by Chulalongkorn University.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteopenia
- What is being tested?
- Calcium from fish bone and Calcium carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Efficacy and Safety of Calcium From Fish Bone in Volunteers With Osteopenia
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.
Read the 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
- Osteopenia
- Being tested
- Calcium from fish bone, Calcium carbonate
- Keywords
- osteopenia, calcium, fish bone, efficacy, safety
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium from fish boneDietary supplement
Calcium from fish bone contained calcium 312 mg and vitamin D 100 IU per capsule.
Calcium carbonateDietary supplement
Calcium carbonate contained calcium 600 mg and vitamin D 200 IU per capsule.
| Study group | Role | What they receive |
|---|---|---|
| Calcium from fish bone | Experimental | The volunteer will receive calcium from fish bone 4 capsules per day for 6 months. Receives: Dietary Supplement: Calcium from fish bone |
| Calcium carbonate | Active comparator | The volunteer will receive calcium carbonate 2 tablets per day for 6 months. Receives: Dietary Supplement: Calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (17)
Osteocalcin level
Changing of osteocalcin level of calcium from fish bone group compared to calcium carbonate group.
Measured: 6 months
Total procollagen type-1 N-terminal propeptide (P1NP) level
Changing of P1NP level of calcium from fish bone group compared to calcium carbonate group.
Measured: 6 months
Beta-crosslaps level
Changing of beta-crosslaps level of calcium from fish bone group compared to calcium carbonate group.
Measured: 6 months
Parathyroid hormone (PTH) level
Changing of PTH level of calcium from fish bone group compared to calcium carbonate group.
Measured: 6 months
Blood calcium level
Changing of blood calcium level of calcium from fish bone group compared to calcium carbonate group.
Measured: 6 months
Blood phosphate level
Changing of blood phosphate level of calcium from fish bone group compared to calcium carbonate group.
Measured: 6 months
Vitamin D level
Changing of vitamin D level of calcium from fish bone group compared to calcium carbonate group.
Measured: 6 months
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.
Measured: 6 months
Creatinine level
Changing of creatinine (Cr) level of calcium from fish bone group compared to calcium carbonate group.
Measured: 6 months
Blood urea nitrogen level
Changing of blood urea nitrogen (BUN) of calcium from fish bone group compared to calcium carbonate group.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Grip strength
Changing of grip strength (kilogram) of calcium from fish bone group compared to calcium carbonate group.
Measured: 6 months
Skin allergic reactions
The outcome measurements of skin allergic reactions are appearance (have or no have) of rash, edema, bullae, pain, and itching.
Measured: 6 months
Respiratory tract abnormality
The outcome measurements of respiratory tract abnormality are appearance (have or no have) of shortness of breath and asthma.
Measured: 6 months
Gastrointestinal tract abnormality
The outcome measurements of gastrointestinal tract abnormality are appearance (have or no have) of nausea, vomiting, flatulence, constipation, and diarrhea.
Measured: 6 months
Satisfaction level
Satisfaction score (0 unsatisfied to 10 very satisfied)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start20 May 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381168
- Sponsor's protocol ID
- 176/64
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Calcium From Fish Bone in Volunteers With Osteopenia
- ClinicalTrials.gov ID
- NCT05381168
- Acronym / sponsor ID
- 176/64
- Conditions
- Osteopenia
- Keywords
- osteopenia, calcium, fish bone, efficacy, safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 20 May 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Calcium from fish bone | Experimental | Dietary Supplement: Calcium from fish boneThe volunteer will receive calcium from fish bone 4 capsules per day for 6 months. |
| Calcium carbonate | Active comparator | Dietary Supplement: Calcium carbonateThe volunteer will receive calcium carbonate 2 tablets per day for 6 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium from fish boneCalcium from fish bone contained calcium 312 mg and vitamin D 100 IU per capsule. | Dietary supplement | Calcium from fish bone |
| Calcium carbonateCalcium carbonate contained calcium 600 mg and vitamin D 200 IU per capsule. | Dietary supplement | Calcium carbonate |
Primary outcome
Bone mineral density score
Time frame: 6 months
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.
17 secondary outcomes
Osteocalcin level
Time frame: 6 months
Total procollagen type-1 N-terminal propeptide (P1NP) level
Time frame: 6 months
Beta-crosslaps level
Time frame: 6 months
Parathyroid hormone (PTH) level
Time frame: 6 months
Blood calcium level
Time frame: 6 months
Blood phosphate level
Time frame: 6 months
Vitamin D level
Time frame: 6 months
Liver function level
Time frame: 6 months
Creatinine level
Time frame: 6 months
Blood urea nitrogen level
Time frame: 6 months
Pain score
Time frame: 6 months
Short physical performance battery score
Time frame: 6 months
Grip strength
Time frame: 6 months
Skin allergic reactions
Time frame: 6 months
Respiratory tract abnormality
Time frame: 6 months
Gastrointestinal tract abnormality
Time frame: 6 months
Satisfaction level
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium from fish bone and Calcium carbonate in people with Osteopenia, run by Chulalongkorn University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.