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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
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteopenia focused on measuring osteopenia, calcium, fish bone, efficacy, safety

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 5, 2022
    Last Updated
    May 18, 2022
    Sponsor
    Chulalongkorn University
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    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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