Calcium From Fish Bone in Volunteers With Osteopenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-20

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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

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Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Calcium from fish bone

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

Group Type EXPERIMENTAL

Calcium from fish bone

Intervention Type DIETARY_SUPPLEMENT

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

Calcium carbonate

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

Group Type ACTIVE_COMPARATOR

Calcium carbonate

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Calcium from fish bone

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

Intervention Type DIETARY_SUPPLEMENT

Calcium carbonate

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes