Calcium From Fish Bone in Volunteers With Osteopenia

Sponsor

Chulalongkorn University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05381168

Collaborator

(none)

Enrollment

Arms

7.4

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Osteopenia	Dietary Supplement: Calcium from fish bone Dietary Supplement: Calcium carbonate	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Efficacy and Safety of Calcium From Fish Bone in Volunteers With Osteopenia

Anticipated Study Start Date :

May 20, 2022

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Calcium from fish bone The volunteer will receive calcium from fish bone 4 capsules per day for 6 months.	Dietary Supplement: Calcium from fish bone Calcium from fish bone contained calcium 312 mg and vitamin D 100 IU per capsule.
Active Comparator: Calcium carbonate The volunteer will receive calcium carbonate 2 tablets per day for 6 months.	Dietary Supplement: Calcium carbonate Calcium carbonate contained calcium 600 mg and vitamin D 200 IU per capsule.

Arm

Intervention/Treatment

Experimental: Calcium from fish bone

The volunteer will receive calcium from fish bone 4 capsules per day for 6 months.

Dietary Supplement: Calcium from fish bone

Calcium from fish bone contained calcium 312 mg and vitamin D 100 IU per capsule.

Active Comparator: Calcium carbonate

The volunteer will receive calcium carbonate 2 tablets per day for 6 months.

Dietary Supplement: Calcium carbonate

Calcium carbonate contained calcium 600 mg and vitamin D 200 IU per capsule.

Outcome Measures

Primary Outcome Measures

Bone mineral density score [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.

Secondary Outcome Measures

Osteocalcin level [6 months]
Changing of osteocalcin level of calcium from fish bone group compared to calcium carbonate group.
Total procollagen type-1 N-terminal propeptide (P1NP) level [6 months]
Changing of P1NP level of calcium from fish bone group compared to calcium carbonate group.
Beta-crosslaps level [6 months]
Changing of beta-crosslaps level of calcium from fish bone group compared to calcium carbonate group.
Parathyroid hormone (PTH) level [6 months]
Changing of PTH level of calcium from fish bone group compared to calcium carbonate group.
Blood calcium level [6 months]
Changing of blood calcium level of calcium from fish bone group compared to calcium carbonate group.
Blood phosphate level [6 months]
Changing of blood phosphate level of calcium from fish bone group compared to calcium carbonate group.
Vitamin D level [6 months]
Changing of vitamin D level of calcium from fish bone group compared to calcium carbonate group.
Liver function level [6 months]
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 [6 months]
Changing of creatinine (Cr) level of calcium from fish bone group compared to calcium carbonate group.
Blood urea nitrogen level [6 months]
Changing of blood urea nitrogen (BUN) of calcium from fish bone group compared to calcium carbonate group.
Pain score [6 months]
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 [6 months]
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 [6 months]
Changing of grip strength (kilogram) of calcium from fish bone group compared to calcium carbonate group.
Skin allergic reactions [6 months]
The outcome measurements of skin allergic reactions are appearance (have or no have) of rash, edema, bullae, pain, and itching.
Respiratory tract abnormality [6 months]
The outcome measurements of respiratory tract abnormality are appearance (have or no have) of shortness of breath and asthma.
Gastrointestinal tract abnormality [6 months]
The outcome measurements of gastrointestinal tract abnormality are appearance (have or no have) of nausea, vomiting, flatulence, constipation, and diarrhea.
Satisfaction level [6 months]
Satisfaction score (0 unsatisfied to 10 very satisfied)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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