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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|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)|
|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|
therapy induced anemia for HCV treated patients
Four types of interventions:
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
- 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
- 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
- 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
- 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).
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
|National Research Centre|
|Giza, Al Jizah, Egypt, 12411|
|Principal Investigator:||Ammal M Metwally||National research centre|