Calcium From Fish Bone in Volunteers With Osteopenia
- Conditions
- Osteopenia
- Interventions
- Dietary Supplement: Calcium carbonateDietary Supplement: Calcium from fish bone
- Registration Number
- NCT05381168
- Lead Sponsor
- Chulalongkorn University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Calcium carbonate Calcium carbonate The volunteer will receive calcium carbonate 2 tablets per day for 6 months. Calcium from fish bone Calcium from fish bone The volunteer will receive calcium from fish bone 4 capsules per day for 6 months.
- Primary Outcome Measures
Name Time Method Bone mineral density score 6 months 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
Name Time Method Blood urea nitrogen level 6 months Changing of blood urea nitrogen (BUN) of calcium from fish bone group compared to calcium carbonate group.
Vitamin D level 6 months Changing of vitamin D level of calcium from fish bone group compared to calcium carbonate group.
Blood calcium level 6 months Changing of blood calcium level of calcium from fish bone group compared to calcium carbonate group.
Parathyroid hormone (PTH) level 6 months Changing of PTH level of calcium from fish bone group compared to calcium carbonate group.
Short physical performance battery score 6 months 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 6 months Changing of grip strength (kilogram) of calcium from fish bone group compared to calcium carbonate group.
Satisfaction level 6 months Satisfaction score (0 unsatisfied to 10 very satisfied)
Blood phosphate level 6 months Changing of blood phosphate level of calcium from fish bone group compared to calcium carbonate group.
Pain score 6 months 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.
Gastrointestinal tract abnormality 6 months The outcome measurements of gastrointestinal tract abnormality are appearance (have or no have) of nausea, vomiting, flatulence, constipation, and diarrhea.
Osteocalcin level 6 months Changing of osteocalcin level of calcium from fish bone group compared to calcium carbonate group.
Total procollagen type-1 N-terminal propeptide (P1NP) level 6 months Changing of P1NP level of calcium from fish bone group compared to calcium carbonate group.
Beta-crosslaps level 6 months Changing of beta-crosslaps level of calcium from fish bone group compared to calcium carbonate group.
Liver function level 6 months 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 6 months Changing of creatinine (Cr) level of calcium from fish bone group compared to calcium carbonate group.
Skin allergic reactions 6 months The outcome measurements of skin allergic reactions are appearance (have or no have) of rash, edema, bullae, pain, and itching.
Respiratory tract abnormality 6 months The outcome measurements of respiratory tract abnormality are appearance (have or no have) of shortness of breath and asthma.