Study to evaluate the efficacy and safety of salmon protein hydrolyate in whey protein isolate powder to improve hemoglobin and serum ferritin in anaemic patients

Phase 4

• Conditions: Health Condition 1: null- Anemia

• Registration Number: CTRI/2014/02/004433
• Lead Sponsor: Hofseth Biocare AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

1. Understand and voluntarily sign an informed consent form.

2. Able to adhere to the study visit schedule and other protocol requirements.

3. Women and Men with Hemoglobin concentration >= 8 g/dL and < 11 g/dL.

4. Situational anemia.

Exclusion Criteria

1. Red blood cell transfusions within the past 3 months.

2. Estimated glomerular filtration rate (eGFR) of < 30 ml/min (by abbreviated

MDRD).

3. Use of erythropoiesis stimulating agents (ESA) in the past 3 months.

4. Active infection defined as symptomatic, requiring active treatment (prophylaxis

allowed) or hospitalized for > 24 hours primarily for infection within the past

month.

5. Uncontrolled hypertension defined as diastolic blood pressure > 100 mm Hg or

systolic blood pressure > 160 mm Hg on 2 separate occasions during screening

Period.

6. Other primary uncorrected cause for anemia including:

a. Known active inflammatory disease including autoimmune diseases (e.g.,

systemic lupus erythematosis, rheumatoid arthritis, mixed connective tissue

disease, sarcoidosis, bronchiolitis obliterans, vasculitis, polymyalgia

rheumatica, temporal artheritis).

b. Chronic active infection (e.g., HIV, viral hepatitis).

c. Acute infection within past 3 months (pneumonia, sepsis, bacteremia,

prostatitis).

d. Receipt of immunosuppressive therapy in the past 2 years.

e. Any cancer (aside from nonmelanoma skin cancer) in the past 2 years or on

therapy for cancer.

7. Elevated AST or ALT >= 2x upper limit of normal.

8. Total bilirubin > 1.5 mg/dL.

9. Use of any other experimental drug or therapy within 28 days of initial screening

visit.

10. Dementia defined as the inability to independently provide informed consent.

11. Recent history of Gastroin test bleed.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the effect of Whey Tech Pro Gold (TM) to increase hemoglobin in anemic patientsTimepoint: At baseline (Day 1), Day 30 and Day 50

Secondary Outcome Measures

Name	Time	Method
To determine the efficacy of Whey Tech Pro Gold (TM) on following parameters: <br/ ><br>Serum ferritin and bile acid levels. <br/ ><br>Quality of life. <br/ ><br>Verify the health safety of Whey Tech Pro Gold (TM) using a standard physical system.Timepoint: At baseline (Day 1), Day 30 and Day 50