Breast Cancer FemaleEarly Phase 1NCT05331807
Omega-3 and Vitamin D Supplementation in Breast Cancer Women
A Early Phase 1 study testing Omega-3 FA, Vitamin D and Combined Omega-3 and Vitamin D Supplementation in people with Breast Cancer Female, run by Universiti Sains Malaysia at 1 site in Palestinian Territories.
Trial summary
Breast cancer (BC) is the most common malignant disease, which is fifth leading cause of cancer mortality worldwide. Poor nutritional status is one of the common physical symptoms found among cancer patients, in which it is caused by both cancer disease state and its oncology treatment regimens used. Read more about this study
- Who is it for?
- Ages 19 to 64 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Omega-3 FA, Vitamin D and Combined Omega-3 and Vitamin D Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 20 Apr 2022to 31 Mar 2023
- Phase
- Early Phase 1
- 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 19 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females who have been newly diagnosed with the breast cancer of stage I, II and III
- Patients with following clinical diagnosis of breast cancer such as lymph node positive +ve, hormonal receptor negative -ve and human epidermal growth factor receptor 2 (HER2) negative -ve
- Patient will receive her first chemotherapy treatment with Adriamycin + Cytoxan (AC) for a total of four cycle (each cycle will be carried-out every 3 weeks (21 days)
Who cannot join
- Participants who had already undertaken her chemotherapy previously, and/or other oncology treatments such as hormonal or radiation oncology therapy
- Patients with recurrent breast cancer, patients with other chronic disease conditions such as renal disease and under dialysis, HIV, malabsorption disorder diseases, autoimmune diseases, diabetes, hypertension, hepatic, parathyroid, and gastrointestinal disorders.
- Patients who have reported any allergy condition to fish and/or fish products
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Turkish-Palestinian Friendship Hospital
Al-Zahra', Gaza Strip, 890
About this study
Official title: The Effects of Combined Omega-3 and Vitamin D Supplementation on Nutritional Status, Quality of Life and Inflammatory Markers Among the Breast Cancer Women in Gaza Strip
Breast cancer (BC) is the most common malignant disease, which is fifth leading cause of cancer mortality worldwide. Poor nutritional status is one of the common physical symptoms found among cancer patients, in which it is caused by both cancer disease state and its oncology treatment regimens used. Cancer patients develop a tumor-associated malnutrition characterized by an insufficient supply of macro- and micronutrients and systemic chemotherapy treatment that could significantly affecting the nutritional status of these patients by its side effects associated with chemotherapy that may lead to many medical complications that often requires hospitalization and death. An adequate nutritional intervention can have a beneficial impact on the disease condition and also the progress of the disease, as an integral part of adjuvant therapy on cancer care. Numerous studies had shown that the use of EPA and DHA are safe (absence of cardiotoxic effects) and effective in reducing the common chemotherapy-related side effects, such as bone density loss, peripheral neuropathy and weight gain. The question remains arises to whether administration of both vitamin D and omega-3 fatty acids supplementations could be used as important nutritional strategy during the active oncology treatment in breast cancer patients. In Palestine, nutritional intervention strategies are poorly evaluated in the oncology setting especially among patients undergoing chemotherapy. Suitable and proper nutritional interventions among breast cancer patients during active oncology treatments could help to improve nutritional status, decrease mortality and improve quality of life among these subjects. Hence, the present study is formulated to assess the effect of combined omega-3 fatty acid and vitamin D supplementation on the nutritional status, quality of life and blood inflammatory markers among breast cancer women undergoing chemotherapy treatment in the Gaza Strip, Palestine.
Read the detailed description
An adequate nutritional intervention can have a beneficial impacts on the disease condition and also the progress of the disease, as an integral part of adjuvant therapy on cancer care. Numerous clinical and epidemiological studies had found that vitamin D deficiency is common nutritional disorder in BC patients and that significantly associated with a negative prognostic factor, in which some have reported a positive effect of combining vitamin D or its analogues as an adjuvant therapy, together with a variety of chemotherapeutic factors used during oncology treatments. Moreover, combination of vitamin D and omega-3 fatty acids may provide a new complementary treatment by decreasing inflammatory biomarkers and resistance to cancer treatment in patients with BC. The question remains whether vitamin D and omega-3 fatty acids co-supplementation would actually be useful after diagnosis of BC. So, the aim of this study is to investigate the effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory biomarkers, and nutritional status in patients with BC.
- Conditions
- Breast Cancer Female
- Being tested
- Omega-3 FA, Vitamin D, Combined Omega-3 and Vitamin D Supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 FADietary supplement
Two capsules of 1000mg fish oil daily (Each soft gel capsule contains 180mg EPA and 120 mg DHA)
Vitamin DDietary supplement
one capsule of vitamin D3 weekly (one D3 capsule contains 50,000 IU)
Combined Omega-3 and Vitamin D SupplementationCombination product
Two capsules of 1000mg fish oil daily (Each soft gel capsule contains 180mg EPA and 120 mg DHA) and one capsule of vitamin D3 weekly (one D3 capsule contains 50,000 IU)
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | Participants will be received daily omega-3 fatty acid (two capsules of 1000mg fish oil daily). Each soft gel capsule contains 300 mg of omega-3 fatty acids in the bioactive triglyceride (TG) and 180mg EPA and 120 mg DHA. (Omega3 complex, Jamieson Laboratories, Canada) Receives: Dietary Supplement: Omega-3 FA |
| Group (B) | Experimental | Participants will be received only vitamin D (one capsule of 50,000IU weekly). Each film coated tablet of vitamin D contains 50,000 IU Vitamin D3 (Cholecalciferol). (J-Dee, Jerusalem Pharmaceutical Company, West bank, Palestine). Receives: Dietary Supplement: Vitamin D |
| Group (C) | Experimental | Participants will be received both omega-3 fatty acids capsules and vitamin D3 capsule. (one capsule of D3 50,000 IU weekly + two omega-3 fatty acids capsules daily (each capsule contains 300 mg of omega-3 fatty acids) Receives: Combination Product: Combined Omega-3 and Vitamin D Supplementation |
| Group (D) | No intervention | Participants will not be received any supplements and just receive oncology treatment as an usual oncology patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Nutritional status, as assessed by Body Mass Index
Body weight in kilograms and height in meters will be combined to report BMI in kg/m^2
Measured: Change from Baseline BMI at 2 months
Change of body weight
Body weight will be measured in kilograms
Measured: Change from Baseline Weight in kg at 2 months
Change of Muscle Mass Status
Muscle mass status will be assessed by calf circumference levels in cm. Higher values of calf circumference is indicative of greater lean mass.
Measured: Change from Baseline calf circumference in cm at 2 months
Change of Nutritional Status Condition, as assessed by the Patient-Generated Subjective Global Assessment PG-SGA
The PG-SGA will be based four components such as questions related to body weight status (scored 0-5), food intake (score 0-4); symptoms affecting oral food intake (scored 0-23), and lastly questions on daily activities and function, in which the degree of malnutrition of patients will be classified as (A) well-nourished; (B) moderately malnourished; or (C) severely malnourished.
Measured: Change from Baseline Nutritional Status Condition in category of well-nourished, moderately malnourished or severely malnourished at 2 months
Change of Total Scale and Single-item measures Scores derived from the Quality of life questionnaire (QLQ C-30) assessment
The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) assessment of 30 questions to measure cancer patients' physical, psychological and social functions. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
Measured: Change from Baseline total scales and single-item measures scores (0 to 100 scores) at 2 months
Change of Blood inflammatory markers of blood TNF-α levels
Blood concentration of TNF-α levels will be measured in unit pg/mL.
Measured: Change from baseline TNF-α levels in pg/mL at 2 months
Change of Blood inflammatory markers of blood CRP levels
Blood concentration of CRP levels will be measured in nmol/L
Measured: Change from baseline CRP levels in nmol/L at 2 months
Change of Nutritional Status Assessed by body weight levels
Body weight will be measured in kilograms
Measured: Change from baseline weight in kg at 2 months
Secondary outcomes (5)
Change of Dietary Energy Intakes
Habitual dietary nutrients intake will be assessed by mean energy intakes in kcal
Measured: Change from Baseline dietary energy intakes in kcal at 2 months
Change of Dietary Fat Intakes
Habitual dietary nutrients intake will be assessed by mean fat intakes in grams
Measured: Change from Baseline dietary fat intakes in grams at 2 months
Change of Dietary Protein Intakes
Habitual dietary protein intakes will be assessed by mean protein intakes in grams
Measured: Change from Baseline dietary Protein intakes in grams at 2 months
Change of Dietary Vitamin D intakes
Habitual dietary nutrients intake will be assessed by mean vitamin D intakes in micrograms
Measured: Change from Baseline Dietary Vitamin D Intakes in microgram at 2 months
Lifestyle physical activity status
A short form of the international physical activity questionnaire (IPAQ) will be used to assess the physical activity levels of the study participants, in which three different category groups of inactive, minimally active and active will be categorised.
Measured: Change from Baseline Physical Activity Status (inactive, minimally active or active physical activity status) at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start20 Apr 2022
- Primary completion30 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open-label randomized clinical trial of breast cancer women that are undergoing chemotherapy treatment for total duration of 2 months (approximately 9 weeks in total), in which participants will be randomly selected and included in either one of these four (4) experimental groups (arms).
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leng Huat Foo, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331807
- Sponsor's protocol ID
- 21090645
- Status last verified
- May 2024
- First submitted
- 18 Mar 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almassri HF, Abdul Kadir A, Srour M, Foo LH. The Effects of Omega-3 Fatty Acids and Vitamin D Supplementation on the Nutritional Status of Women with Breast Cancer in Palestine: An Open-Label Randomized Controlled Trial. Nutrients. 2024 Nov 20;16(22):3960. doi: 10.3390/nu16223960.
PubMed 39599746Almassri HF, Abdul Kadir A, Srour M, Foo LH. The effects of Omega-3 fatty acids and vitamin D supplementation on the quality of life and blood inflammation markers in newly diagnosed breast cancer women: An open-labelled randomised controlled trial. Clin Nutr ESPEN. 2025 Feb;65:64-75. doi: 10.1016/j.clnesp.2024.11.014. Epub 2024 Nov 20.
PubMed 39577691
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combined Omega-3 and Vitamin D Supplementation on Nutritional Status, Quality of Life and Inflammatory Markers Among the Breast Cancer Women in Gaza Strip
- ClinicalTrials.gov ID
- NCT05331807
- Acronym / sponsor ID
- 21090645
- Conditions
- Breast Cancer Female
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 18 Apr 2022 (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.
Breast cancer (BC) is the most common malignant disease, which is fifth leading cause of cancer mortality worldwide. Poor nutritional status is one of the common physical symptoms found among cancer patients, in which it is caused by both cancer disease state and its oncology treatment regimens used. Cancer patients develop a tumor-associated malnutrition characterized by an insufficient supply of macro- and micronutrients and systemic chemotherapy treatment that could significantly affecting the nutritional status of these patients by its side effects associated with chemotherapy that may lead to many medical complications that often requires hospitalization and death. An adequate nutritional intervention can have a beneficial impact on the disease condition and also the progress of the disease, as an integral part of adjuvant therapy on cancer care. Numerous studies had shown that the use of EPA and DHA are safe (absence of cardiotoxic effects) and effective in reducing the common chemotherapy-related side effects, such as bone density loss, peripheral neuropathy and weight gain. The question remains arises to whether administration of both vitamin D and omega-3 fatty acids supplementations could be used as important nutritional strategy during the active oncology treatment in breast cancer patients. In Palestine, nutritional intervention strategies are poorly evaluated in the oncology setting especially among patients undergoing chemotherapy. Suitable and proper nutritional interventions among breast cancer patients during active oncology treatments could help to improve nutritional status, decrease mortality and improve quality of life among these subjects. Hence, the present study is formulated to assess the effect of combined omega-3 fatty acid and vitamin D supplementation on the nutritional status, quality of life and blood inflammatory markers among breast cancer women undergoing chemotherapy treatment in the Gaza Strip, Palestine.
Detailed description
An adequate nutritional intervention can have a beneficial impacts on the disease condition and also the progress of the disease, as an integral part of adjuvant therapy on cancer care. Numerous clinical and epidemiological studies had found that vitamin D deficiency is common nutritional disorder in BC patients and that significantly associated with a negative prognostic factor, in which some have reported a positive effect of combining vitamin D or its analogues as an adjuvant therapy, together with a variety of chemotherapeutic factors used during oncology treatments. Moreover, combination of vitamin D and omega-3 fatty acids may provide a new complementary treatment by decreasing inflammatory biomarkers and resistance to cancer treatment in patients with BC. The question remains whether vitamin D and omega-3 fatty acids co-supplementation would actually be useful after diagnosis of BC. So, the aim of this study is to investigate the effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory biomarkers, and nutritional status in patients with BC.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- An open-label randomized clinical trial of breast cancer women that are undergoing chemotherapy treatment for total duration of 2 months (approximately 9 weeks in total), in which participants will be randomly selected and included in either one of these four (4) experimental groups (arms).
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Dietary Supplement: Omega-3 FAParticipants will be received daily omega-3 fatty acid (two capsules of 1000mg fish oil daily). Each soft gel capsule contains 300 mg of omega-3 fatty acids in the bioactive triglyceride (TG) and 180mg EPA and 120 mg DHA. (Omega3 complex, Jamieson Laboratories, Canada) |
| Group (B) | Experimental | Dietary Supplement: Vitamin DParticipants will be received only vitamin D (one capsule of 50,000IU weekly). Each film coated tablet of vitamin D contains 50,000 IU Vitamin D3 (Cholecalciferol). (J-Dee, Jerusalem Pharmaceutical Company, West bank, Palestine). |
| Group (C) | Experimental | Combination Product: Combined Omega-3 and Vitamin D SupplementationParticipants will be received both omega-3 fatty acids capsules and vitamin D3 capsule. (one capsule of D3 50,000 IU weekly + two omega-3 fatty acids capsules daily (each capsule contains 300 mg of omega-3 fatty acids) |
| Group (D) | No intervention | –Participants will not be received any supplements and just receive oncology treatment as an usual oncology patient. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females who have been newly diagnosed with the breast cancer of stage I, II and III
- Patients with following clinical diagnosis of breast cancer such as lymph node positive +ve, hormonal receptor negative -ve and human epidermal growth factor receptor 2 (HER2) negative -ve
- Patient will receive her first chemotherapy treatment with Adriamycin + Cytoxan (AC) for a total of four cycle (each cycle will be carried-out every 3 weeks (21 days)
Key exclusion criteria (4 listed)
- Participants who had already undertaken her chemotherapy previously, and/or other oncology treatments such as hormonal or radiation oncology therapy
- Patients with recurrent breast cancer, patients with other chronic disease conditions such as renal disease and under dialysis, HIV, malabsorption disorder diseases, autoimmune diseases, diabetes, hypertension, hepatic, parathyroid, and gastrointestinal disorders.
- Patients who have reported any allergy condition to fish and/or fish products
- Pregnant women
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 |
|---|---|---|
| Omega-3 FATwo capsules of 1000mg fish oil daily (Each soft gel capsule contains 180mg EPA and 120 mg DHA) | Dietary supplement | Group (A) |
| Vitamin Done capsule of vitamin D3 weekly (one D3 capsule contains 50,000 IU) | Dietary supplement | Group (B) |
| Combined Omega-3 and Vitamin D SupplementationTwo capsules of 1000mg fish oil daily (Each soft gel capsule contains 180mg EPA and 120 mg DHA) and one capsule of vitamin D3 weekly (one D3 capsule contains 50,000 IU) | Combination product | Group (C) |
Primary outcome
Change of Nutritional status, as assessed by Body Mass Index
Time frame: Change from Baseline BMI at 2 months
Body weight in kilograms and height in meters will be combined to report BMI in kg/m^2
Change of body weight
Time frame: Change from Baseline Weight in kg at 2 months
Body weight will be measured in kilograms
Change of Muscle Mass Status
Time frame: Change from Baseline calf circumference in cm at 2 months
Muscle mass status will be assessed by calf circumference levels in cm. Higher values of calf circumference is indicative of greater lean mass.
Change of Nutritional Status Condition, as assessed by the Patient-Generated Subjective Global Assessment PG-SGA
Time frame: Change from Baseline Nutritional Status Condition in category of well-nourished, moderately malnourished or severely malnourished at 2 months
The PG-SGA will be based four components such as questions related to body weight status (scored 0-5), food intake (score 0-4); symptoms affecting oral food intake (scored 0-23), and lastly questions on daily activities and function, in which the degree of malnutrition of patients will be classified as (A) well-nourished; (B) moderately malnourished; or (C) severely malnourished.
Change of Total Scale and Single-item measures Scores derived from the Quality of life questionnaire (QLQ C-30) assessment
Time frame: Change from Baseline total scales and single-item measures scores (0 to 100 scores) at 2 months
The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) assessment of 30 questions to measure cancer patients' physical, psychological and social functions. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
Change of Blood inflammatory markers of blood TNF-α levels
Time frame: Change from baseline TNF-α levels in pg/mL at 2 months
Blood concentration of TNF-α levels will be measured in unit pg/mL.
Change of Blood inflammatory markers of blood CRP levels
Time frame: Change from baseline CRP levels in nmol/L at 2 months
Blood concentration of CRP levels will be measured in nmol/L
Change of Nutritional Status Assessed by body weight levels
Time frame: Change from baseline weight in kg at 2 months
Body weight will be measured in kilograms
5 secondary outcomes
Change of Dietary Energy Intakes
Time frame: Change from Baseline dietary energy intakes in kcal at 2 months
Change of Dietary Fat Intakes
Time frame: Change from Baseline dietary fat intakes in grams at 2 months
Change of Dietary Protein Intakes
Time frame: Change from Baseline dietary Protein intakes in grams at 2 months
Change of Dietary Vitamin D intakes
Time frame: Change from Baseline Dietary Vitamin D Intakes in microgram at 2 months
Lifestyle physical activity status
Time frame: Change from Baseline Physical Activity Status (inactive, minimally active or active physical activity status) at 2 months
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 8 May 2024.
- Derived from this study: PubMed 39599746Almassri HF, Abdul Kadir A, Srour M, Foo LH. The Effects of Omega-3 Fatty Acids and Vitamin D Supplementation on the Nutritional Status of Women with Breast Cancer in Palestine: An Open-Label Randomized Controlled Trial. Nutrients. 2024 Nov 20;16(22):3960. doi: 10.3390/nu16223960.
- Derived from this study: PubMed 39577691Almassri HF, Abdul Kadir A, Srour M, Foo LH. The effects of Omega-3 fatty acids and vitamin D supplementation on the quality of life and blood inflammation markers in newly diagnosed breast cancer women: An open-labelled randomised controlled trial. Clin Nutr ESPEN. 2025 Feb;65:64-75. doi: 10.1016/j.clnesp.2024.11.014. Epub 2024 Nov 20.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Omega-3 FA, Vitamin D and Combined Omega-3 and Vitamin D Supplementation in people with Breast Cancer Female, run by Universiti Sains Malaysia at 1 site in Palestinian Territories.
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 3 inclusion and 4 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 8 May 2024. 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 Palestinian Territories. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change of Nutritional status, as assessed by Body Mass Index (time frame: Change from Baseline BMI at 2 months). The study lists 8 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 NCT05331807, which also lists 2 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 8 May 2024.