Anemia, Iron DeficiencyNCT04271865
Dates a Food Treasure in Alleviating Anemia
A study testing Nutritional Education, model nutrition kitchen and recipe book in people with Anemia, Iron Deficiency, run by National Research Centre, Egypt at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anemia, Iron Deficiency
- What is being tested?
- Nutritional Education, model nutrition kitchen and recipe book
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Feb 2017to 25 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Improving the lives of the anaemic patients by providing a set of interventions for to alleviate their anaemia
- improving participants' quality of life which was Dates fruits dependant.
This study was conducted as three phases:
The first phase included:
- Equipping the three main primary health care units by automated cell counter
- Training of the primary health care technicians to carry out screening for risk of anaemia
- 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
- 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 :
- Measuring change in the haemoglobin level
- Measuring the change of the nutritional habits for all anaemic cases'
- 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
- Conditions
- Anemia, Iron Deficiency
- Being tested
- Nutritional Education, model nutrition kitchen, recipe book, Provision of Dates
- Keywords
- HCV treated patients, Anemia, Dates
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nutritional Education; Other: model nutrition kitchen; Other: recipe book; Other: Provision of Dates |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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 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
Measured: 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
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).
Measured: The difference from the initial (before the intervention) with that of four months after the initiation of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start26 Feb 2017
- Primary completion15 Jul 2019
- Study completion25 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- providing Dates fruits as a potential palliative remedy to mitigate anaemia combined with nutritional education
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Taibah University, Rotary club of Heliopolis Sporting, Egypt, Australian Embassy of Egypt, Sustainable Development Project in the Kingdom of Saudi Arabia (KSA)
- Responsible party
- Principal investigator, Prof.Dr. Ammal Mokhtar Metwally, National Research Centre, Egypt
- Investigators
- Ammal M Metwally, Principal investigator, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271865
- Sponsor's protocol ID
- 20171226
- Status last verified
- Feb 2020
- First submitted
- 12 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) that underlie in a publication results will be shared
Publications
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)
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.
PubMed 1593914Newby 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.
PubMed 14594780Rock 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.
PubMed 19681613Al-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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04271865
- Acronym / sponsor ID
- 20171226
- Conditions
- Anemia, Iron Deficiency
- Keywords
- HCV treated patients, Anemia, Dates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Collaborators
- Taibah University, Rotary club of Heliopolis Sporting, Egypt, Australian Embassy of Egypt, Sustainable Development Project in the Kingdom of Saudi Arabia (KSA)
- Study start
- 26 Feb 2017 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 25 Dec 2019 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Improving the lives of the anaemic patients by providing a set of interventions for to alleviate their anaemia
- improving participants' quality of life which was Dates fruits dependant.
This study was conducted as three phases:
The first phase included:
- Equipping the three main primary health care units by automated cell counter
- Training of the primary health care technicians to carry out screening for risk of anaemia
- 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
- 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 :
- Measuring change in the haemoglobin level
- Measuring the change of the nutritional habits for all anaemic cases'
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- providing Dates fruits as a potential palliative remedy to mitigate anaemia combined with nutritional education
| Arm | Type | Receives |
|---|---|---|
| therapy induced anemia for HCV treated patients | Other | Other: Nutritional Education, Other: model nutrition kitchen, Other: recipe book, Other: Provision of DatesFour 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional EducationProvision 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 | therapy induced anemia for HCV treated patients |
| model nutrition kitchenImplementing 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 | therapy induced anemia for HCV treated patients |
| recipe book3) 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 | therapy induced anemia for HCV treated patients |
| Provision of DatesDates 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 | Other | therapy induced anemia for HCV treated patients |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- BackgroundWHO. 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: PubMed 1593914Ware 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.
- Background: PubMed 14594780Newby 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.
- Background: PubMed 19681613Rock 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.
- BackgroundAl-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
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie in a publication results will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ammal M Metwally principal investigator
National Research Centre, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Education, model nutrition kitchen and recipe book in people with Anemia, Iron Deficiency, run by National Research Centre, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change of the mean Hb level as a result of interventions (time frame: Four months after the initiation of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04271865, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.