CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 131 enrolled
Drug / intervention
Nutritional Education +3 moreother
Likely dose
Not stated in record
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Search/NCT04271865
NCT04271865N/ACompleted

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

National Research Centre, Egypt·interventional·Posted Feb 17, 2020·Updated Feb 17, 2020

In Brief

A clinical study evaluating Nutritional Education, model nutrition kitchen, and 2 other interventions for Anemia, Iron Deficiency. Completed, enrolled 131 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 17, 2020
Enrollment StartFeb 26, 2017
Primary CompletionJul 15, 2019
Study CompletionDec 25, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.4 years ago

Interventions

Nutritional Educationother

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

model nutrition kitchenother

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.

recipe bookother

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

Provision of Datesother

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