Calcium From Fish Bone in Volunteers With Osteopenia

Osteopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05381168
• Other study ID #: 176/64
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Bone mineral density, blood examination, physical examination, adverse events, and satisfaction are evaluated before and after treatment.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia

Intervention

Dietary Supplement:
• Calcium from fish bone
Calcium from fish bone contained calcium 312 mg and vitamin D 100 IU per capsule.
• Calcium carbonate
Calcium carbonate contained calcium 600 mg and vitamin D 200 IU per capsule.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Outcome

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