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Effectiveness of Calcium and Vitamin D, With and Without Collagen Peptide, in Enhancing Bone Mineral Density on Postmenopausal Women With Osteopenia

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06464718
Enrollment
30
Registered
2024-06-18
Start date
2022-06-20
Completion date
2023-01-16
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia

Keywords

Bone mineral density, collagen peptide, osteoporosis, osteopenia, vitamin D3

Brief 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.

Detailed 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.

Interventions

DRUGFortibone

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).

calcium compound containing 25 g calcium carbonate (500mg elemental calcium) and vitamin D3 400IU taken daily

Sponsors

Frontier Medical and Dental College, Abbotabad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Group A comprised of 15 subject who 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). Group B (control) consisted of 15 subjects who consumed a sweet formed from a chewable tablet with 1. A calcium compound containing 25 g calcium carbonate (500mg elemental calcium) and vitamin D3 400IU taken daily, these are potent supplements that are often used in practice, as per the researchers' recommendations

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Postmenopausal patients * (-1. 0\>T-score\>-2. 5)

Exclusion criteria

* fracture, * primary hyperparathyroidism

Design outcomes

Primary

MeasureTime frameDescription
Blood Testbaseline and after 3 monthsCalcium levels in blood
Dexa Scanbaseline and after 3 monthsBone Mineral Density

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026