Calcium From Fish Bone in Volunteers With Osteopenia

Chulalongkorn University48 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Osteopenia

Interventions

Calcium from fish boneDIETARY_SUPPLEMENT

Calcium from fish bone contained calcium 312 mg and vitamin D 100 IU per capsule.

Calcium carbonateDIETARY_SUPPLEMENT

Calcium carbonate contained calcium 600 mg and vitamin D 200 IU per capsule.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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