An interventional study of Calcium from fish bone and Calcium carbonate in Osteopenia, sponsored by Chulalongkorn University. Status unknown. Per ClinicalTrials.gov, last updated 2022-05-19.
Sponsored by Chulalongkorn University · Not applicable, Interventional, and Prevention
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.
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.
470 studies on the registry are indexed under Bone Diseases, Metabolic; 71 are open to participants now.
This study's planned enrollment of 48 is below the median of 60 across 359 interventional studies indexed under Bone Diseases, Metabolic.
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Exclusion Criteria:
The volunteer will receive calcium from fish bone 4 capsules per day for 6 months.
Dietary Supplement: Calcium from fish bone
The volunteer will receive calcium carbonate 2 tablets per day for 6 months.
Dietary Supplement: Calcium carbonate
Calcium from fish bone contained calcium 312 mg and vitamin D 100 IU per capsule.
Calcium carbonate contained calcium 600 mg and vitamin D 200 IU per capsule.
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.
Time frame: 6 months
Osteocalcin level
Changing of osteocalcin level of calcium from fish bone group compared to calcium carbonate group.
Time frame: 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.
Time frame: 6 months
Beta-crosslaps level
Changing of beta-crosslaps level of calcium from fish bone group compared to calcium carbonate group.
Time frame: 6 months
Parathyroid hormone (PTH) level
Changing of PTH level of calcium from fish bone group compared to calcium carbonate group.
Time frame: 6 months
Blood calcium level
Changing of blood calcium level of calcium from fish bone group compared to calcium carbonate group.
Time frame: 6 months
Blood phosphate level
Changing of blood phosphate level of calcium from fish bone group compared to calcium carbonate group.
Time frame: 6 months
Vitamin D level
Changing of vitamin D level of calcium from fish bone group compared to calcium carbonate group.
Time frame: 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.
Time frame: 6 months
Creatinine level
Changing of creatinine (Cr) level of calcium from fish bone group compared to calcium carbonate group.
Time frame: 6 months
Blood urea nitrogen level
Changing of blood urea nitrogen (BUN) of calcium from fish bone group compared to calcium carbonate group.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Grip strength
Changing of grip strength (kilogram) of calcium from fish bone group compared to calcium carbonate group.
Time frame: 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.
Time frame: 6 months
Respiratory tract abnormality
The outcome measurements of respiratory tract abnormality are appearance (have or no have) of shortness of breath and asthma.
Time frame: 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.
Time frame: 6 months
Satisfaction level
Satisfaction score (0 unsatisfied to 10 very satisfied)
Time frame: 6 months
No study locations are listed for this record.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Chulalongkorn University