Effectiveness of Calcium and Vitamin D, With and Without... | NCT06464718

Brief Title

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.

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 20, 2022Actual

Primary Completion Date

Dec 10, 2022Actual

Completion Date

Jan 16, 2023Actual

First Submitted Date

Jun 13, 2024

First Submission Date that Met QC Criteria

Jun 13, 2024

First Posted Date

Jun 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2024

Last Update Posted Date

Jun 24, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Saif ur Rehman, Professor, Frontier Medical and Dental College, AbbotabadPrincipal Investigator

Lead Sponsor

Frontier Medical and Dental College, AbbotabadOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fortibone	Experimental		Drug: Fortibone
Chewable Tablet	Active Comparator		Drug: Chewable Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fortibone	Drug	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Test	Calcium levels in blood	baseline and after 3 months
Blood Test	Vitamin B	baseline and after 3 months
Blood Test	Osteocalcin	baseline and after 3 months
Dexa Scan	Bone Mineral Density	baseline and after 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

fracture,
primary hyperparathyroidism

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Postmenopausal

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Frontier Medical and Dental College		Abbottābād	KPK		Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

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

Masking Info

Masking

None (Open Label)

Masking Description

Not provided

Who Masked

Not provided

ID	Term
D001851	Bone Diseases, Metabolic
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases