Calcium From Fish Bone in Volunteers With Osteopenia

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteopenia
• Intervention / Treatment: Dietary supplement: Calcium from fish bone; Dietary supplement: Calcium carbonate

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 Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osteocalcin level	Changing of osteocalcin level of calcium from fish bone group compared to calcium carbonate group.	6 months
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
Beta-crosslaps level	Changing of beta-crosslaps level of calcium from fish bone group compared to calcium carbonate group.	6 months
Parathyroid hormone (PTH) level	Changing of PTH level of calcium from fish bone group compared to calcium carbonate group.	6 months
Blood calcium level	Changing of blood calcium level of calcium from fish bone group compared to calcium carbonate group.	6 months
Blood phosphate level	Changing of blood phosphate level of calcium from fish bone group compared to calcium carbonate group.	6 months
Vitamin D level	Changing of vitamin D level of calcium from fish bone group compared to calcium carbonate group.	6 months
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
Creatinine level	Changing of creatinine (Cr) level of calcium from fish bone group compared to calcium carbonate group.	6 months
Blood urea nitrogen level	Changing of blood urea nitrogen (BUN) of calcium from fish bone group compared to calcium carbonate group.	6 months
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
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
Grip strength	Changing of grip strength (kilogram) of calcium from fish bone group compared to calcium carbonate group.	6 months
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
Respiratory tract abnormality	The outcome measurements of respiratory tract abnormality are appearance (have or no have) of shortness of breath and asthma.	6 months
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
Satisfaction level	Satisfaction score (0 unsatisfied to 10 very satisfied)	6 months

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 20, 2022
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: safety; efficacy; osteopenia; calcium; fish bone
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Antacids; Calcium; Calcium, Dietary; Calcium Carbonate
• Other Study ID Numbers: 176/64

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No