Calcium From Fish Bone in Volunteers With Osteopenia

NCT05381168 | Unknown

• 1 other identifier: 176/64
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteopenia

Keywords

osteopenia; calcium; fish bone; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (17)

• Osteocalcin level

  6 months

• Total procollagen type-1 N-terminal propeptide (P1NP) level

  6 months

• Beta-crosslaps level

  6 months

• Parathyroid hormone (PTH) level

  6 months

• Blood calcium level

  6 months

Study Arms (2)

Calcium from fish bone

EXPERIMENTAL

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

Dietary Supplement: Calcium from fish bone

Calcium carbonate

ACTIVE COMPARATOR

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

Dietary Supplement: Calcium carbonate

Interventions

Calcium from fish bone DIETARY_SUPPLEMENT

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

Calcium from fish bone

Calcium carbonate DIETARY_SUPPLEMENT

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

Calcium carbonate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 19, 2022
• Study Start: May 20, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05