Clinical trial NCT04271865: Dates a Food Treasure in Alleviating Anemia
Official title: Dates a Food Treasure: Use of Dates Fruit in Alleviating and Managing Therapy-induced Anaemia for Hepatitis C Patients in Seven Villages of Egypt With Improving Their Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia, Iron Deficiency
Keywords: HCV treated patients
Anemia
Dates
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
Collaborators: name: Taibah University
name: Rotary club of Heliopolis Sporting, Egypt
name: Australian Embassy of Egypt
name: Sustainable Development Project in the Kingdom of Saudi Arabia (KSA)
First posted: 2020-02-17
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: providing Dates fruits as a potential palliative remedy to mitigate anaemia combined with nutritional education
Primary purpose: TREATMENT

Brief summary: Introduction: In May 2016, seven villages in three governorates of Egypt were declared to be the first villages free from hepatitis C upon eliminating HCV virus by treatment with Sofosbuvir plus ribavirin (an interferon-free regimen). These patients were amounted to 2340 cases out of 19,991 screened residents of the seven villages within three governorates of Egypt. Although this combination was proved effective (95 %) in treatment of HCV genotype 4 among Egyptians, yet it resulted in anaemia with decreased quality of life for the majority of the treated HCV patients.

Aim of the project: To assess and manage therapy-induced anaemia among 2340 treated chronic hepatitis C patients with Sofosbuvir plus ribavirin, and improving their quality of life by provision of a comprehensive nutritional interventions that is based on Dates fruit intake.

Methodology: Dates fruit intake for all the diagnosed anaemic patients was provided for 16 weeks (four months). Five pieces of Dates fruit were taken as breakfast on daily basis (each date fruits is about 10 -20 gm). The Dates fruit that was used was Saudi's Dates extract known as Barni which is organic Dates. This Barni is known for its very high nutritive value (vitamins, minerals and antioxidants) compared with other Dates types. This Dates was imported from Saudi Arabia as donation through collaboration between NRC with Taibah University and Sustainable Development Project in the Kingdom of Saudi Arabia (KSA). In addition to Dates fruit intake, nutritional education to alleviate their anaemia was also provided. Haemoglobin level, risk of malnutrition and health-related quality of life (HRQoL) were assessed in all anemic patients before and after four months of intervention.

Detailed description: Anaemia is a condition in which the number of red blood cells or their oxygen-carrying capacity is insufficient to meet physiologic needs. Anemia is a condition characterized by a decrease in the concentration of hemoglobin in the blood. Hemoglobin is necessary for transporting oxygen to tissues and organs in the body. Iron deficiency is thought to be the most common cause of anaemia globally. Iron deficiency anemia is due to insufficient iron that is necessary to produce enough red blood cells that enables them to carry oxygen (hemoglobin). As a result, iron deficiency anemia is associated with fatigue, general body weakness, frequent tiredness, dizziness and lowered resistance to disease and drowsiness. Overall, morbidity and mortality risks increase for individuals suffering from anemia, a condition in which blood lacks adequate healthy red blood cells. Red blood cells carry oxygen to the body's tissues.

Anemia is considered a serious public health problem worldwide with prevalence of 43% in the developing countries and of 9% in the developed ones. Research demonstrates that the majority of HCV treated patients with ribavirin became anaemic after treatment and they claimed that their quality of life was affected because of anaemia. Anaemia is one of the common side effects for Hepatitis C treated with ribavirin and remains a prominent concern. Partially, because Ribavirin destroys red blood cells by causing them to break open, or rupture and partially because of malnutrition due to the loss of appetite accompanying the treatment. Moreover addition of direct acting antiviral as Sofosbuvir to peginterferon plus ribavirin (PegIFN/RBV) increases the frequency as well as the severity, and hence, clinical relevance of anaemia, which has now become one of the major complications associated with hepatitis C therapy. Most significant factors associated with anaemia in patients receiving triple therapy include older age, lower body mass index (BMI), advanced fibrosis, and lower baseline haemoglobin.

Hemoglobin lower than normallevels indicate anemia; The normal hemoglobin range is generally defined as 13.2 to 16.6 grams (g) of hemoglobin per deciliter (dL) of blood for men and 11.6 to 15. g/dL for women. Severe anemia is manifested when Hb level is less than 8 grams (g) of hemoglobin per deciliter (dL) for both adult men aged 15 years and above and non- pregnant women aged 15 years and above Overall objective To help program planners plan regimens and guidelines to overcome therapy-induced anaemia with the use of functional food Objectives for direct beneficiaries

1. Improving the lives of the anaemic patients by providing a set of interventions for to alleviate their anaemia
2. improving participants' quality of life which was Dates fruits dependant.

This study was conducted as three phases:

The first phase included:

1. Equipping the three main primary health care units by automated cell counter
2. Training of the primary health care technicians to carry out screening for risk of anaemia
3. Screening and assessing incidence of anaemia and measuring haemoglobin concentration (Hb) among 2341 HCV treated cases (\>18 years to 70 years) followed by confirming the anaemic status
4. Assessing the nutritional pattern and quality of life for the anaemic cases

The second phase included:

* Development of recipe book to increase the number of nutritionally balanced meals and increase the frequency of iron-rich foods per week
* Provision of awareness and educational sessions at the community based associations for improving the patients' own nutrition situation through nutritional education about food rich in iron and counselling. Special focus will be on increasing patients' awareness for self-management of their status.
* Provision of Dates : Dates fruit intake for all the anaemic patients was provided for 16 weeks (four months):Diagnosed anemic patients were given five pieces of Dates on daily basis for 16 weeks (each date fruits is about 10 -20 gm), of Dates. Dates was taken as breakfast on daily base.
* Provision of demonstration kitchen model

the third phase was the evaluation phase for :

1. Measuring change in the haemoglobin level
2. Measuring the change of the nutritional habits for all anaemic cases'
3. Measuring change of the quality of life indicators

Monitoring process:

A monthly monitoring sheet containing pictures and photos for the types of food was used for follow up of dietary habits. It was filled daily by the cases starting from the first day after the session for one month. Follow up was done for 6 months

Eligibility criteria: Inclusion Criteria:

* therapy induced anemia (HCV treated cases with anemia)

Hemoglobin lower than normal levels indicating mild and moderate anemia. The normal hemoglobin range is generally defined as 13.2 to 16.6 grams (g) of hemoglobin per deciliter (dL) of blood for men and 11.6 to 15. g/dL for women.

Exclusion Criteria:

* Severe anemia is manifested when HB level is less than 8 grams (g) of hemoglobin per deciliter (dL) for both adult men aged 15 years and above and non- pregnant women aged 15 years and above

Primary outcomes:
measure: Percent change of the mean Hb level as a result of interventions
timeFrame: Four months after the initiation of the intervention
measure: percent change of the severity of anaemia
timeFrame: difference from the initial (before the intervention) with that four months after the initiation of the intervention
Secondary outcomes:
measure: Percent change of diet quality as a result of the interventions (as measured by the Diet Quality Index (DQI)
timeFrame: The difference from the initial (before the intervention) with that of four months after the initiation of the intervention
measure: Percent change of the Health related quality of life (HRQoL) as a result of interventions
timeFrame: The difference from the initial (before the intervention) with that of four months after the initiation of the intervention
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: National Research Centre
state: Al Jizah
Study officials:
affiliation: National Research Centre, Egypt
name: Ammal M Metwally
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Al-Radadi, N.S. Green synthesis of platinum nanoparticles using Saudi's Dates extract and their usage on the cancer cell treatment. Arabian Journal of Chemistry .2019; 12, 330-349