Dates a Food Treasure in Alleviating Anemia

NCT04271865 | Completed DMC

• 1 other identifier: 20171226
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia, Iron Deficiency

Keywords

HCV treated patients; Anemia; Dates

Outcome Measures

Primary Outcomes (2)

• Percent change of the mean Hb level as a result of interventions

  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

  Four months after the initiation of the intervention

• percent change of the severity of anaemia

  The percent change of the severity of anaemia from mild to moderate or severe and the reversed was measured as per each participants

  difference from the initial (before the intervention) with that four months after the initiation of the intervention

Secondary Outcomes (2)

• Percent change of diet quality as a result of the interventions (as measured by the Diet Quality Index (DQI)

  The difference from the initial (before the intervention) with that of four months after the initiation of the intervention

• Percent change of the Health related quality of life (HRQoL) as a result of interventions

  The difference from the initial (before the intervention) with that of four months after the initiation of the intervention

Study Arms (1)

therapy induced anemia for HCV treated patients

OTHER

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; Other: model nutrition kitchen; Other: recipe book; Other: Provision of Dates

Interventions

Nutritional Education OTHER

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

therapy induced anemia for HCV treated patients

model nutrition kitchen OTHER

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.

therapy induced anemia for HCV treated patients

recipe book OTHER

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

therapy induced anemia for HCV treated patients

Provision of Dates OTHER

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

therapy induced anemia for HCV treated patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Research Centre, Egypt: lead
• Taibah University: collaborator
• Rotary club of Heliopolis Sporting, Egypt: collaborator
• Australian Embassy of Egypt: collaborator
• Sustainable Development Project in the Kingdom of Saudi Arabia (KSA): collaborator

Study Sites (1)

National Research Centre

Giza, Giza Governorate, 12411, Egypt

Location

Related Publications (5)

• WHO. Haemoglobin concentrations for the diagnosis of anaemia and assessment of severity. Vitamin and Mineral Nutrition Information System. Geneva, World Health Organization, 2011 (WHO/NMH/NHD/MNM/11.1)

  BACKGROUND

• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

  PMID: 1593914 BACKGROUND

• Newby PK, Hu FB, Rimm EB, Smith-Warner SA, Feskanich D, Sampson L, Willett WC. Reproducibility and validity of the Diet Quality Index Revised as assessed by use of a food-frequency questionnaire. Am J Clin Nutr. 2003 Nov;78(5):941-9. doi: 10.1093/ajcn/78.5.941.

  PMID: 14594780 BACKGROUND

• Rock W, Rosenblat M, Borochov-Neori H, Volkova N, Judeinstein S, Elias M, Aviram M. Effects of date ( Phoenix dactylifera L., Medjool or Hallawi Variety) consumption by healthy subjects on serum glucose and lipid levels and on serum oxidative status: a pilot study. J Agric Food Chem. 2009 Sep 9;57(17):8010-7. doi: 10.1021/jf901559a.

  PMID: 19681613 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ammal M Metwally

  National Research Centre, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: providing Dates fruits as a potential palliative remedy to mitigate anaemia combined with nutritional education

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: February 26, 2017
• Primary Completion: July 15, 2019
• Study Completion: December 25, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after the study publication
• Access Criteria: the data will be accessed through a link

Locations

EG (1)