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The effects of Colostrum and Whey protein supplements in Pelvic and Femur fracture patients

The effects of Colostrum and Whey protein supplementation on rate of union, wound healing, functional activity and C reactive protein in Pelvic and Femur fracture patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220424054643N1
Enrollment
340
Registered
2022-06-01
Start date
2022-04-26
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

Pelvic and Femur fracture. Fracture of acetabulum

Interventions

Intervention 1: The Intervention group: This group has 175 member which receive 40 grams of Colostrum powder daily for 21 days. Each 100 grams of this powder contains 25 grams of protein, 37.6 grams o

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Willingness to cooperate and complete the informed consent form by the patient or legal guardian Patients 18 to 65 years Pelvic and hip fractures Body mass index < 35 kg / m2 Candidate for pelvic and femoral fixation surgery Active movement without assistance from 2 months before fracture

Exclusion criteria

Exclusion criteria: Need to other supplement due to a specific problem (kidney, lung, liver, etc.) Have diabetes Have Gastrointestinal diseases malabsorption Have parathyroid gland disorders Have hepatic encephalopathy and the liver cirrhosis Have recent myocardial infarction Have uncompensated congestive heart failure Have lower limb amputation Existence the symptoms of angina Have Chest pain or dyspnea (including severe COPD) Have kidney failure Have metastatic cancer Have infection and sepsis Have uncontrolled blood pressure Have cognitive impairment (3MS score> 73) Take drugs that affect bone metabolism, such as calcitonin, bisphosphonates and corticosteroids Take supplements or formulas to strengthen the immune system, including: arginine, glutamine, vitamins C and E, selenium, zinc or omega-3 fatty acids in the last 2 weeks before the intervention Have allergy or lactose intolerance Participate in other clinical trial studies at the same time as the present study

Design outcomes

Primary

MeasureTime frame
Comparison of bone union rate. Timepoint: Bone union is assessed at 1, 3 and 6 months after surgery. Method of measurement: Radiography.

Secondary

MeasureTime frame
Comparison of C-reactive protein concentrations. Timepoint: Serum C-reactive protein is measured at baseline and 10 days after surgery. Method of measurement: Blood sample.;Assessment of wound healing and the incidence of infection. Timepoint: The wound healing and the incidence of infection are assessed at 10 days; 1 month and 3 months after surgery. Method of measurement: Southampton wound scoring system.;Comparison of postoperative pain. Timepoint: The pain is assessed at the beginning of the study; 10 days; one month and 3 months after surgery. Method of measurement: Visual Analogue Scale.;Comparison of disability after surgery. Timepoint: The degree of inability is assessed at beginning; one month and 3 months after surgery. Method of measurement: Oswestry disability index.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaeze Gouhari

Shahid Beheshti University of Medical Sciences

gouhari71nutr@gmail.com+98 21 2235 7483

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 6, 2026