Calcium From Fish Bone in Volunteers With Osteopenia

Chulalongkorn University

Status: Unknown

Conditions: Osteopenia

Treatments: Dietary Supplement: Calcium from fish bone; Dietary Supplement: Calcium carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT05381168

176/64

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

48 participants in 2 patient groups

Calcium from fish bone

Experimental group

Description:

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

Treatment:

Dietary Supplement: Calcium from fish bone

Calcium carbonate

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Calcium carbonate