Severe Acute MalnutritionPhase 3NCT04053218
Intervening to Repair Cognitive and Behavioural Problems in Adults Exposed to Childhood Malnutrition
A Phase 3 study testing Exercise plus omega-3 supplement in people with Severe Acute Malnutrition and Cognitive Impairment, run by The University of The West Indies at 1 site in Jamaica.
Trial summary
Globally, in 2011, 52 million children under 5 years old suffered from acute malnutrition, and a further 165 million children showed evidence of chronic undernutrition or stunting. It was also estimated that 3.1 million children died in 2011 of malnutrition related causes. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Acute Malnutrition, Cognitive Impairment, Emotional Disturbances
- What is being tested?
- Exercise plus omega-3 supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteJamaica
- Study dates
- 15 Jan 2018to 14 Dec 2020
- Phase
- Phase 3
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- SAM survivors, both males and females and between the ages of 20 and 50 years
- Community controls will be identified from the same street address as the cases and matched for sex, age ±5 years.
Who cannot join
- Pregnancy
- Unstable angina or myocardial infarction diagnosed within 3 months;
- Heart failure (New York Heart Association category 2) or significant valvular dysfunction;
- Peripheral arterial disease with claudication, major orthopaedic, chronic pain, or neuromuscular disorders restricting exercise;
- Pulmonary or renal failure;
- Poorly controlled hypertension (>190/110 mmHg) on two separate occasions, or type 2 diabetes mellitus, or type 1 diabetes mellitus regardless of control;
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- Recent hospitalisation for severe disease or surgery;
- Regularly exercises at moderate or vigorous intensity for more than 30 minutes three times or more per week;
- Is currently taking daily omega-3 supplements for over two weeks.
Trial locations and contacts
1 site in 1 country.
Jamaica1 site, 1 recruiting
- Recruiting
University of the West Indies
Kingston
Terrence Forrester, PhD, 876-977-6803, terrence.forrester@uwimona.edu.jm
Michael S Boyne, PhD, 876-927-1621, michael.boyne@uwimona.edu.jm
About this study
Official title: Intervening to Repair Neuropsychological Deficits in Adult Survivors of Severe Childhood Malnutrition
Globally, in 2011, 52 million children under 5 years old suffered from acute malnutrition, and a further 165 million children showed evidence of chronic undernutrition or stunting. It was also estimated that 3.1 million children died in 2011 of malnutrition related causes. The survivors, due to deprivation of critical nutrients in the most important period of development and growth, are left with permanent damage, including an increased risk of cardio-metabolic disease, poorer educational achievement and diminished earning potential.
In Jamaica in 2012, 2.5% of children were moderately or severely underweight (more than two standard deviations below weight-for-age by international reference populations), falling from as high as 8.9% in 1993. Though there have been modest reductions in the incidence of acute malnutrition in Jamaica over the past 20 years, the risk remains high in poor families and among children who are being weaned. Hence, the problem is an ongoing one and we have a significant pool of survivors of childhood malnutrition who have now reached adulthood and face the consequences of early nutrient deprivation.
Read more
The brain is particularly vulnerable to the effects of malnutrition and studies have demonstrated both structural (brain atrophy) and functional (cognitive impairment and poor academic achievement) changes. This evidence, however, has been mainly in later childhood and adolescence. In addition, there is local data that suggests that cardio-metabolic risk factors are increased in these adult survivors, which are well-described precursors of cerebrovascular disease and cognitive impairment. Therefore, in adulthood there may be accelerated cognitive decline due to a poor cardio-metabolic profile superimposed on pre-existing brain injury.
We hypothesise that there are differences in cognitive function (poorer memory and executive function)and emotional responses in adult survivors of childhood malnutrition compared to those not exposed to early childhood malnutrition.
There is evidence suggesting that aerobic exercise and omega-3 supplementation have some benefit in reversing cognitive decline in older adults, but they have not been investigated in survivors of childhood malnutrition.Hence, we propose to introduce a six month intervention of supervised aerobic exercise and omega-3 supplementation, and will compare cognitive function pre and post intervention/placebo between malnutrition survivors and controls.
Read the detailed description
This study will assess anthropometry, cardio metabolic profiles, cognitive and emotional domains between adult survivors of severe acute malnutrition (SAM) in childhood and healthy controls from similar communities, pre and post a six month intervention of supervised aerobic exercise and omega-3 supplementation.
Recruitment: The cases will include adult SAM survivors admitted to the University Hospital of the West Indies (UHWI) now between 20 and 55 years. They have been identified from UHWI records and traced using last known addresses by experienced field workers. Community controls will be recruited from the same communities, one per case and matched for sex, and age (within 5 years).
Sample Size Calculations: These are based on assessing differences in cognitive function using the NIH (National Institutes of Health) Toolbox Cognitive battery as the primary outcome measure between SAM survivors and community controls, and between pre-and post-intervention groups.
Using a test at the 5% level of statistical significance we will have 80% power to detect a difference of 2.8 √(2/n) standard deviations between cases and controls, where n=number of cases.
Therefore, at n=50, difference= 2.8 √ (2/50) = 0.56 SD
For the NIH Toolbox, raw scores are converted to a normalized score, where 100 is equivalent to the normative mean for the relevant age/education stratification, and 15 units corresponds to 1 standard deviation (SD).
For n=50, 0.56 x 15 = 8.4 units. So, using a test at the 5% level of statistical significance we will have 80% power to detect a difference of 8.4 units between the two groups. Meta-analyses on intervention studies of cognitive changes with aerobic exercise have shown a medium effect size of approximately 0.48-0.57, (154) which corresponds to 7.2-8.5 units. Hence, using 50 subjects per group will provide an adequate sample size.
Standard Operating Procedures:
After obtaining informed written consent, all baseline data will be collected by one of two trained researchers over one to two visits. These tests will be repeated after the six-month intervention.
Details of Methods to be used:
Anthropometry: Height and weight will be measured with subjects without shoes and in light clothing to calculate body mass index (BMI, kg/m2). Weight will be measured to the nearest 0.1kg. Height will be measured to the nearest 0.1cm.
Dual-energy X-ray absorption (DXA) (Model General Electric Lunar Prodigy) will be used to measure total and regional percent (%) body fat, fat mass, lean tissue mass, and bone mineral content.
Blood Pressure: Participants will be rested for >10 minutes seated in a temperature controlled environment. Blood pressure will be measured three times on the right arm using an automatic blood pressure monitor with at least 30 seconds in between each reading. The three measurements will be averaged for analysis. The mid upper arm circumference will be measured to determine the appropriate sized blood pressure cuff.
Fitness Testing: Subjects will exercise to voluntary exhaustion during a treadmill test using a modified Bruce protocol. Oxygen consumption, carbon dioxide production, and minute ventilation will be measured breath-by-breath using a metabolic cart and the average of the final three 20 second values of oxygen consumption will be the maximum rate of oxygen consumption.
Cognitive Tests: The NIH Toolbox, a computerised, neurocognitive test battery will be used to assess cognitive and emotion domains. In the cognitive domain, this study will assess executive function, cognitive flexibility, inhibitory control, attention, episodic memory, working memory and processing speed.
For the emotion domain, we will use a self-report battery and test four central subdomains including psychological well-being, social relationships, stress and self-efficacy and negative affect.
Blood Tests: 30 millilitres of blood will be taken in the fasted state for assessment of plasma levels of insulin and glucose, lipids, brain-derived neurotrophic factor, insulin-like growth factor and omega-3 fatty acid profile in erythrocytes. A full oral glucose tolerance test will be done with samples for glucose and insulin at 30 minutes, 60 minutes, 90 minutes and 120 minutes after 75 grams glucose orally.
Data Analysis:
Descriptive data will be provided calculated for all variables. Multiple linear regression analysis will be used to determine if there are any differences in outcome variables between survivors and controls. These analyses will be controlled for potential confounding variables such as age, sex and socio-economic status. The size of effects will be assessed as the regression coefficient for a binary treatment variable. Change in cognitive outcomes will be assessed by including the baseline measure of cognitive function as a predictor. Interaction tests will be used to assess whether any treatment effect differs by baseline cognitive function, age, sex and socio-economic status.
- Being tested
- Exercise plus omega-3 supplement, Placebo
- Keywords
- Adult survivors of severe acute malnutrition, Cognition
- Medical subject headings
- Severe Acute Malnutrition, Cognitive Dysfunction, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise plus omega-3 supplementCombination product
Supervised aerobic exercise and omega-3 supplement
PlaceboDietary supplement
Olive oil placebo
| Study group | Role | What they receive |
|---|---|---|
| Exercise and supplement | Active comparator | Supervised aerobic exercise three times weekly and daily omega-3 supplements Receives: Combination Product: Exercise plus omega-3 supplement |
| Placebo | Placebo comparator | Olive oil capsules. No supervised exercise but written recommendations for daily physical activity from the American Heart Association Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition
NIH Toolbox Computerized Cognitive Battery
Measured: Six months
Secondary outcomes (1)
Emotional disturbances
NIH Toolbox self reported emotion domain
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start15 Jan 2018
- Primary completion7 Sep 2020 (estimated)
- Study completion14 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Severe Acute MalnutritionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be enrolled in one of two groups, exercise and omega-3 supplementation or placebo group. Subjects and controls in the first group will receive supervised aerobic exercise on a treadmill, targeting 75-85% heart rate reserve for 45 minutes per session, three days per week. Each participant's heart rate reserve will be calculated using the formula: Heart rate reserve=maximal heart rate - resting heart rate. Each participant in this group will also receive an omega-3 supplement containing 2 grams /day. The placebo group will receive 2 grams of olive oil (mainly oleic acid, a monounsaturated fatty acid) and standardised health education, face-to-face and written (American Heart Association educational materials), including recommendations for regular physical activity and nutrition.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terrence E Forrester, DM, PhD, Principal investigator, University of the West Indies, Mona Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053218
- Sponsor's protocol ID
- ECP235,15/16
- Status last verified
- Aug 2019
- First submitted
- 7 Aug 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Francis-Emmanuel PM, Thompson DS, Barnett AT, Osmond C, Byrne CD, Hanson MA, Gluckman PD, Forrester TE, Boyne MS. Glucose metabolism in adult survivors of severe acute malnutrition. J Clin Endocrinol Metab. 2014 Jun;99(6):2233-40. doi: 10.1210/jc.2013-3511. Epub 2014 Feb 11.
PubMed 24517147Tennant IA, Barnett AT, Thompson DS, Kips J, Boyne MS, Chung EE, Chung AP, Osmond C, Hanson MA, Gluckman PD, Segers P, Cruickshank JK, Forrester TE. Impaired cardiovascular structure and function in adult survivors of severe acute malnutrition. Hypertension. 2014 Sep;64(3):664-71. doi: 10.1161/HYPERTENSIONAHA.114.03230. Epub 2014 Jun 30.
PubMed 24980666Angevaren M, Aufdemkampe G, Verhaar HJ, Aleman A, Vanhees L. Physical activity and enhanced fitness to improve cognitive function in older people without known cognitive impairment. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD005381. doi: 10.1002/14651858.CD005381.pub3.
PubMed 18646126Dangour AD, Allen E, Elbourne D, Fletcher A, Richards M, Uauy R. Fish consumption and cognitive function among older people in the UK: baseline data from the OPAL study. J Nutr Health Aging. 2009 Mar;13(3):198-202. doi: 10.1007/s12603-009-0057-2.
PubMed 19262951
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening to Repair Neuropsychological Deficits in Adult Survivors of Severe Childhood Malnutrition
- ClinicalTrials.gov ID
- NCT04053218
- Acronym / sponsor ID
- ECP235,15/16
- Keywords
- Adult survivors of severe acute malnutrition, Cognition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 7 Sep 2020 (estimated)
- Study completion
- 14 Dec 2020 (estimated)
- First posted
- 12 Aug 2019 (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.
Globally, in 2011, 52 million children under 5 years old suffered from acute malnutrition, and a further 165 million children showed evidence of chronic undernutrition or stunting. It was also estimated that 3.1 million children died in 2011 of malnutrition related causes. The survivors, due to deprivation of critical nutrients in the most important period of development and growth, are left with permanent damage, including an increased risk of cardio-metabolic disease, poorer educational achievement and diminished earning potential.
In Jamaica in 2012, 2.5% of children were moderately or severely underweight (more than two standard deviations below weight-for-age by international reference populations), falling from as high as 8.9% in 1993. Though there have been modest reductions in the incidence of acute malnutrition in Jamaica over the past 20 years, the risk remains high in poor families and among children who are being weaned. Hence, the problem is an ongoing one and we have a significant pool of survivors of childhood malnutrition who have now reached adulthood and face the consequences of early nutrient deprivation.
The brain is particularly vulnerable to the effects of malnutrition and studies have demonstrated both structural (brain atrophy) and functional (cognitive impairment and poor academic achievement) changes. This evidence, however, has been mainly in later childhood and adolescence. In addition, there is local data that suggests that cardio-metabolic risk factors are increased in these adult survivors, which are well-described precursors of cerebrovascular disease and cognitive impairment. Therefore, in adulthood there may be accelerated cognitive decline due to a poor cardio-metabolic profile superimposed on pre-existing brain injury.
We hypothesise that there are differences in cognitive function (poorer memory and executive function)and emotional responses in adult survivors of childhood malnutrition compared to those not exposed to early childhood malnutrition.
There is evidence suggesting that aerobic exercise and omega-3 supplementation have some benefit in reversing cognitive decline in older adults, but they have not been investigated in survivors of childhood malnutrition.Hence, we propose to introduce a six month intervention of supervised aerobic exercise and omega-3 supplementation, and will compare cognitive function pre and post intervention/placebo between malnutrition survivors and controls.
Detailed description
This study will assess anthropometry, cardio metabolic profiles, cognitive and emotional domains between adult survivors of severe acute malnutrition (SAM) in childhood and healthy controls from similar communities, pre and post a six month intervention of supervised aerobic exercise and omega-3 supplementation.
Recruitment: The cases will include adult SAM survivors admitted to the University Hospital of the West Indies (UHWI) now between 20 and 55 years. They have been identified from UHWI records and traced using last known addresses by experienced field workers. Community controls will be recruited from the same communities, one per case and matched for sex, and age (within 5 years).
Sample Size Calculations: These are based on assessing differences in cognitive function using the NIH (National Institutes of Health) Toolbox Cognitive battery as the primary outcome measure between SAM survivors and community controls, and between pre-and post-intervention groups.
Using a test at the 5% level of statistical significance we will have 80% power to detect a difference of 2.8 √(2/n) standard deviations between cases and controls, where n=number of cases.
Therefore, at n=50, difference= 2.8 √ (2/50) = 0.56 SD
For the NIH Toolbox, raw scores are converted to a normalized score, where 100 is equivalent to the normative mean for the relevant age/education stratification, and 15 units corresponds to 1 standard deviation (SD).
For n=50, 0.56 x 15 = 8.4 units. So, using a test at the 5% level of statistical significance we will have 80% power to detect a difference of 8.4 units between the two groups. Meta-analyses on intervention studies of cognitive changes with aerobic exercise have shown a medium effect size of approximately 0.48-0.57, (154) which corresponds to 7.2-8.5 units. Hence, using 50 subjects per group will provide an adequate sample size.
Standard Operating Procedures:
After obtaining informed written consent, all baseline data will be collected by one of two trained researchers over one to two visits. These tests will be repeated after the six-month intervention.
Details of Methods to be used:
Anthropometry: Height and weight will be measured with subjects without shoes and in light clothing to calculate body mass index (BMI, kg/m2). Weight will be measured to the nearest 0.1kg. Height will be measured to the nearest 0.1cm.
Dual-energy X-ray absorption (DXA) (Model General Electric Lunar Prodigy) will be used to measure total and regional percent (%) body fat, fat mass, lean tissue mass, and bone mineral content.
Blood Pressure: Participants will be rested for >10 minutes seated in a temperature controlled environment. Blood pressure will be measured three times on the right arm using an automatic blood pressure monitor with at least 30 seconds in between each reading. The three measurements will be averaged for analysis. The mid upper arm circumference will be measured to determine the appropriate sized blood pressure cuff.
Fitness Testing: Subjects will exercise to voluntary exhaustion during a treadmill test using a modified Bruce protocol. Oxygen consumption, carbon dioxide production, and minute ventilation will be measured breath-by-breath using a metabolic cart and the average of the final three 20 second values of oxygen consumption will be the maximum rate of oxygen consumption.
Cognitive Tests: The NIH Toolbox, a computerised, neurocognitive test battery will be used to assess cognitive and emotion domains. In the cognitive domain, this study will assess executive function, cognitive flexibility, inhibitory control, attention, episodic memory, working memory and processing speed.
For the emotion domain, we will use a self-report battery and test four central subdomains including psychological well-being, social relationships, stress and self-efficacy and negative affect.
Blood Tests: 30 millilitres of blood will be taken in the fasted state for assessment of plasma levels of insulin and glucose, lipids, brain-derived neurotrophic factor, insulin-like growth factor and omega-3 fatty acid profile in erythrocytes. A full oral glucose tolerance test will be done with samples for glucose and insulin at 30 minutes, 60 minutes, 90 minutes and 120 minutes after 75 grams glucose orally.
Data Analysis:
Descriptive data will be provided calculated for all variables. Multiple linear regression analysis will be used to determine if there are any differences in outcome variables between survivors and controls. These analyses will be controlled for potential confounding variables such as age, sex and socio-economic status. The size of effects will be assessed as the regression coefficient for a binary treatment variable. Change in cognitive outcomes will be assessed by including the baseline measure of cognitive function as a predictor. Interaction tests will be used to assess whether any treatment effect differs by baseline cognitive function, age, sex and socio-economic status.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be enrolled in one of two groups, exercise and omega-3 supplementation or placebo group. Subjects and controls in the first group will receive supervised aerobic exercise on a treadmill, targeting 75-85% heart rate reserve for 45 minutes per session, three days per week. Each participant's heart rate reserve will be calculated using the formula: Heart rate reserve=maximal heart rate - resting heart rate. Each participant in this group will also receive an omega-3 supplement containing 2 grams /day. The placebo group will receive 2 grams of olive oil (mainly oleic acid, a monounsaturated fatty acid) and standardised health education, face-to-face and written (American Heart Association educational materials), including recommendations for regular physical activity and nutrition.
| Arm | Type | Receives |
|---|---|---|
| Exercise and supplement | Active comparator | Combination Product: Exercise plus omega-3 supplementSupervised aerobic exercise three times weekly and daily omega-3 supplements |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOlive oil capsules. No supervised exercise but written recommendations for daily physical activity from the American Heart Association |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- SAM survivors, both males and females and between the ages of 20 and 50 years
- Community controls will be identified from the same street address as the cases and matched for sex, age ±5 years.
Key exclusion criteria (9 listed)
- Pregnancy
- Unstable angina or myocardial infarction diagnosed within 3 months;
- Heart failure (New York Heart Association category 2) or significant valvular dysfunction;
- Peripheral arterial disease with claudication, major orthopaedic, chronic pain, or neuromuscular disorders restricting exercise;
- Pulmonary or renal failure;
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 |
|---|---|---|
| Exercise plus omega-3 supplementSupervised aerobic exercise and omega-3 supplement | Combination product | Exercise and supplement |
| PlaceboOlive oil placebo | Dietary supplement | Placebo |
Primary outcome
Cognition
Time frame: Six months
NIH Toolbox Computerized Cognitive Battery
1 secondary outcome
Emotional disturbances
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Background: PubMed 24517147Francis-Emmanuel PM, Thompson DS, Barnett AT, Osmond C, Byrne CD, Hanson MA, Gluckman PD, Forrester TE, Boyne MS. Glucose metabolism in adult survivors of severe acute malnutrition. J Clin Endocrinol Metab. 2014 Jun;99(6):2233-40. doi: 10.1210/jc.2013-3511. Epub 2014 Feb 11.
- Background: PubMed 24980666Tennant IA, Barnett AT, Thompson DS, Kips J, Boyne MS, Chung EE, Chung AP, Osmond C, Hanson MA, Gluckman PD, Segers P, Cruickshank JK, Forrester TE. Impaired cardiovascular structure and function in adult survivors of severe acute malnutrition. Hypertension. 2014 Sep;64(3):664-71. doi: 10.1161/HYPERTENSIONAHA.114.03230. Epub 2014 Jun 30.
- Background: PubMed 18646126Angevaren M, Aufdemkampe G, Verhaar HJ, Aleman A, Vanhees L. Physical activity and enhanced fitness to improve cognitive function in older people without known cognitive impairment. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD005381. doi: 10.1002/14651858.CD005381.pub3.
- Background: PubMed 19262951Dangour AD, Allen E, Elbourne D, Fletcher A, Richards M, Uauy R. Fish consumption and cognitive function among older people in the UK: baseline data from the OPAL study. J Nutr Health Aging. 2009 Mar;13(3):198-202. doi: 10.1007/s12603-009-0057-2.
- Individual participant dataSharing planned: No
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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.
Terrence E Forrester, DM, PhD principal investigator
University of the West Indies, Mona Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise plus omega-3 supplement in people with Severe Acute Malnutrition and Cognitive Impairment, run by The University of The West Indies at 1 site in Jamaica.
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 9 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: status not confirmed, as of the sponsor's last update on 12 Aug 2019. 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 Jamaica. 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. Some participants in this study may receive a placebo. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dean, Faculty of Medicine (876-927-1289, medsci@uwimona.edu.jm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition (time frame: Six months). 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 NCT04053218, which also lists 4 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 12 Aug 2019.