Effectiveness of Calcium and Vitamin D, With and Without Collagen Peptide, in Enhancing Bone Mineral Density on Postmenopausal Women With Osteopenia: Pilot Randomized Controlled Trial.

Osteopenia Clinical Trial

Official title:

Effectiveness of Calcium and Vitamin D, With and Without Collagen Peptide, in Enhancing Bone Mineral Density on Postmenopausal Women With Osteopenia: Pilot Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06464718
• Other study ID #: 3390
• Status: Completed
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: January 16, 2023

Study information

• Verified date: June 2024
• Source: Frontier Medical and Dental College, Abbotabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Osteopenia is characterized by bone mineral density (BMD) being lower than normal but not reaching the osteoporosis threshold, poses a serious problem for women after menopause. Osteopenia is a precursor to osteoporosis that is associated with increased risk of fractures, morbidity, and mortality. Using strategies to improve or maintain bone density is important for preventing osteoporosis and its associated complications. The combination of collagen peptide (CP) with calcium and vitamin D supplementation may provide several ways to improve bone health. This study aims to provide preliminary evidence of the effectiveness of traditional medicine in improving bone health through the effectiveness of CP.

Description:

Osteopenia is characterized by bone mineral density (BMD) being lower than normal but not reaching the osteoporosis threshold, poses a serious problem for women after menopause. Osteopenia is a precursor to osteoporosis that is associated with increased risk of fractures, morbidity, and mortality. Using strategies to improve or maintain bone density is important for preventing osteoporosis and its associated complications. The combination of collagen peptide (CP) with calcium and vitamin D supplementation may provide several ways to improve bone health. This study aims to provide preliminary evidence of the effectiveness of traditional medicine in improving bone health through the effectiveness of CP.The study was single blinded randomized controlled trial, involving 30 post-menopausal women that were equally divided into two groups by computer generated simple random sampling technique. Group A received bioactive collagen peptide along with calcium lactate, and vitamin D3. The control group (Group B) consisted of 15 participants who were given a chewable tablet daily, containing 1.25 grams of calcium carbonate (equivalent to 500 mg of elemental calcium) and 400 IU of vitamin D3.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 16, 2023
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Postmenopausal patients , (-1. 0>T-score>-2. 5)

Exclusion Criteria:

• fracture, primary hyperparathyroidism

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia

Intervention

Drug:
• Fortibone
Participants were given daily sachet containing 5g of Bio active collagen peptides (Fortibone). Electrolyte mix containing 500 mg calcium as calcium lactate, 4 MCg calcitriol and selenised yeast rich in vitamin D3 (400IU) (Colabone®, Vivapharm SA).
• Chewable Tablet
calcium compound containing 25 g calcium carbonate (500mg elemental calcium) and vitamin D3 400IU taken daily

Locations

Country	Name	City	State
Pakistan	Frontier Medical and Dental College	Abbottabad	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Frontier Medical and Dental College, Abbotabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Test	Calcium levels in blood	baseline and after 3 months
Primary	Blood Test	Vitamin B	baseline and after 3 months
Primary	Blood Test	Osteocalcin	baseline and after 3 months
Primary	Dexa Scan	Bone Mineral Density	baseline and after 3 months