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Dates a Food Treasure in Alleviating Anemia

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ClinicalTrials.gov Identifier: NCT04271865
Recruitment Status : Completed
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
Taibah University
Rotary club of Heliopolis Sporting, Egypt
Australian Embassy of Egypt
Sustainable Development Project in the Kingdom of Saudi Arabia (KSA)
Information provided by (Responsible Party):
Prof.Dr. Ammal Mokhtar Metwally, National Research Centre, Egypt

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.


Condition or disease Intervention/treatment Phase
Anemia, Iron Deficiency Other: Nutritional Education Other: model nutrition kitchen Other: recipe book Other: Provision of Dates Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: providing Dates fruits as a potential palliative remedy to mitigate anaemia combined with nutritional education
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 26, 2017
Actual Primary Completion Date : July 15, 2019
Actual Study Completion Date : December 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
therapy induced anemia for HCV treated patients

Four types of interventions:

  • Educational to increase the number of nutritionally balanced meals and increase the frequency of iron-rich foods per day and improve current and risky nutritional habits
  • Provision of Dates : Dates fruit intake for all the anaemic patients
  • Recipe book
  • Model kitchen for all patients having Hemoglobin lower than normal hemoglobin levels; less than 13.2 grams (g) of hemoglobin per deciliter (dL) of blood for men and less than 11.6 for women.
Other: Nutritional Education
Provision of weekly awareness and educational sessions for 6 months. Sessions were conducted at the community based associations within the cases respective villages. Cases were subjected to 24 sessions for improving the patients' own nutrition situation through nutritional education about food rich in iron and counselling. The sessions focused on basic knowledge on iron deficiency anaemia, the most common presenting symptoms, iron rich dietary sources, factors that enhance and inhibit iron absorption, effects of anaemia on health and how to prevent it, Role of dates fruit in preventing and treating anaemia. Th e sessions also focused on the provision of a diverse range of local iron rich food. Special focus was on increasing patients' awareness for self-management of their status

Other: model nutrition kitchen
Implementing model nutrition kitchen; once every month for six months with six sessions for each village (6 sessions/village) with cooking sessions was done to promote eating healthy and provide innovative ideas for feeding anaemic cases. 117 patients were reached by the nutritional kitchen activities with 6 sessions until the end of the project. Special focus was done on skills like sharing cooking, meal planning, and label reading that help support healthy eating patterns. Suggesting ways that individuals can model healthy eating behaviors for friends and family members that is based on Dates fruit was encouraged.

Other: recipe book
3) Development of recipe book that is based on the local food in the market to increase the number of nutritionally balanced meals and increase the frequency of iron-rich foods per day and improve current and risky nutritional habits

Other: Provision of Dates

Dates fruit intake for all the anaemic patients was provided for 16 weeks (four months):

• Diagnosed anemic patients were given five to seven pieces of Dates (dependent on its weight) on daily basis for 16 weeks (each date fruits is about 10 -20 gm). Dates was taken as breakfast on daily base.

The Dates fruit that was used during the proposed trial is Saudi's Dates extract know as Barni which is organic Dates. The fruit is mentioned more than 20 times in the Quran, This Barni is known for its very high nutritive value (vitamins, minerals and antioxidants) compared with other Dates types. The nutritive value of Barni is shown in the below table, calculated per every 100 gram (range 5- 10 pieces) of dry weight (DW) :

The nutritive value of Barni calculated per every 100 gram (average 7-10 pieces) of dry weight (DW) of which iron constitutes 6.78 mg that represent 67.8 % of the recommended dietary allowance (RDA) of the males and 45.20 % of the RDA of the females





Primary Outcome Measures :
  1. Percent change of the mean Hb level as a result of interventions [ Time Frame: Four months after the initiation of the intervention ]

    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. This is according toWorld Health Organization (WHO) for the diagnosis of anaemia and assessment of severity.

    Screening for anaemia by Hemo-Cue then confirmation by the automated cell counter for assessing the incidence of anaemia and measuring haemoglobin concentration (Hb) Both serum iron and ferritin level were measured for confirming the severity of anaemia; mild, moderate and severe anaemia


  2. percent change of the severity of anaemia [ Time Frame: difference from the initial (before the intervention) with that four months after the initiation of the intervention ]
    The percent change of the severity of anaemia from mild to moderate or severe and the reversed was measured as per each participants


Secondary Outcome Measures :
  1. Percent change of diet quality as a result of the interventions (as measured by the Diet Quality Index (DQI) [ Time Frame: The difference from the initial (before the intervention) with that of four months after the initiation of the intervention ]

    The Diet Quality Index (DQI) is an instrument developed to measure overall diet quality that reflects a risk gradient for diet-related chronic disease. Dietary moderation and diversity are 2 new components. DQI-R scores range from 0 to 10 for each component, for a highest possible diet quality score of 100.

    Three levels of malnutrition were defined according to DQI :

    for the risk of anemia and malnutrition :At risk: below 40

    • Possible at risk: 40-50
    • Not at risk: more than 50

  2. Percent change of the Health related quality of life (HRQoL) as a result of interventions [ Time Frame: The difference from the initial (before the intervention) with that of four months after the initiation of the intervention ]
    SF-36 questionnaire for quality of life was implemented. The instrument is extensively validated and has been widely used for assessment of HRQoL in various settings including clinical trials . The questionnaire was provided in Arabic and this was done in the patients' villages. The SF-36 includes 36 questions about patients' perception of wellbeing, health status and daily functioning, which are used to calculate 8 HRQoL domain scores, each ranging from 0 to 100 with higher scores indicating better health: Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04271865


Locations
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Egypt
National Research Centre
Giza, Al Jizah, Egypt, 12411
Sponsors and Collaborators
National Research Centre, Egypt
Taibah University
Rotary club of Heliopolis Sporting, Egypt
Australian Embassy of Egypt
Sustainable Development Project in the Kingdom of Saudi Arabia (KSA)
Investigators
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Principal Investigator: Ammal M Metwally National research centre
Publications:
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Responsible Party: Prof.Dr. Ammal Mokhtar Metwally, Principal Investigator, National Research Centre, Egypt
ClinicalTrials.gov Identifier: NCT04271865    
Other Study ID Numbers: 20171226
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data (IPD) that underlie in a publication results will be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: after the study publication
Access Criteria: the data will be accessed through a link

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof.Dr. Ammal Mokhtar Metwally, National Research Centre, Egypt:
HCV treated patients
Anemia
Dates
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases