Clinical trial NCT06464718: Effectiveness of Calcium and Vitamin D, With and Without Collagen Peptide, in Enhancing Bone Mineral Density on Postmenopausal Women With Osteopenia
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Keywords: Bone mineral density
collagen peptide
osteoporosis
osteopenia
vitamin D3
Lead sponsor: Frontier Medical and Dental College, Abbotabad
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* fracture,
* primary hyperparathyroidism

Primary outcomes:
measure: Blood Test
timeFrame: baseline and after 3 months
measure: Blood Test
timeFrame: baseline and after 3 months
measure: Blood Test
timeFrame: baseline and after 3 months
measure: Dexa Scan
timeFrame: baseline and after 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottābād
country: Pakistan
facility: Frontier Medical and Dental College
state: KPK
Study officials:
References: