MalnutritionNCT01072279
Preventing Malnutrition in Children Under Two Years of Age Approach
A study testing Tubaramure (Burundi) and Procomida (Guatemala) in people with Malnutrition, run by International Food Policy Research Institute at 2 sites in 2 countries.
Trial summary
A study conducted by IFPRI in Haiti provided the first programmatic evidence, using a cluster randomized evaluation design, that preventing child undernutrition in children under two years of age (PM2A) through an integrated program providing food rations, BCC and preventive health and nutrition services is both… Read more about this study
- Who is it for?
- Ages Up to 42 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Tubaramure (Burundi) and Procomida (Guatemala)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,895 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2010to Jun 2015
- 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 Up to 42 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Guatemala: pregnant mothers and subsequently their born children up to the age of 24 months;
- Burundi: cross-sectional study: children 0 to 42 of age.
Who cannot join
- none
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Burundi1 site
CRS Burundi
Bujumbura
About this study
Official title: Strengthening and Evaluating the "Preventing Malnutrition in Children Under Two Years of Age Approach" (PM2A) in Guatemala and Burundi
A study conducted by IFPRI in Haiti provided the first programmatic evidence, using a cluster randomized evaluation design, that preventing child undernutrition in children under two years of age (PM2A) through an integrated program providing food rations, BCC and preventive health and nutrition services is both feasible and highly effective. The study's principal aim was to compare a newly designed preventive approach with the traditional (recuperative) food assisted MCHN program approach, and therefore included only two comparison groups: one group of communities that was randomly assigned to the preventive approach and another group assigned to the recuperative approach. For logistical and financial reasons, the study did not include a randomized control group receiving no intervention.
The Haiti study design was well-suited to achieve its main goal - i.e. to test whether the preventive approach was more effective than the recuperative approach at preventing child undernutrition - but it left a number of questions unanswered.
Read more
The present study will address several of these questions, which will allow to further refine the PM2A approach, facilitate its replication in different contexts, and maximize its impact and cost-effectiveness in future programming. The study will be conducted in Guatemala and Burundi. The key research objectives are:
- Impact and cost effectiveness: Assess the impact and cost effectiveness of PM2A on child nutritional status.
- Optimal composition and size of food rations in PM2A: Assess the differential and absolute impact of varying the size and types of foods incorporated in the food ration of the PM2A. More specifically, assess the differential effect of different sizes of family food rations, and assess the impact of substituting the individual food ration with new micronutrient-rich products such as lipid-based nutrient supplements (LNS) or micronutrient Sprinkles.
- Optimal timing and duration of PM2A: Assess the differential and absolute impact of varying the timing and duration of exposure to PM2A on child nutritional status.
- Conditions
- Malnutrition
- Being tested
- Tubaramure (Burundi), Procomida (Guatemala)
- Keywords
- Malnutrition;, Infant nutrition;, Fortified food, Linear growth, Cluster randomized controlled trials, Effectiveness, Impact evaluation studies, Burundi, Guatemala
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tubaramure (Burundi)Other
Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices
Procomida (Guatemala)Other
Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices
| Study group | Role | What they receive |
|---|---|---|
| Burundi: T24 | Experimental | Not described Receives: Other: Tubaramure (Burundi) |
| Burundi: TNFP | Experimental | Not described Receives: Other: Tubaramure (Burundi) |
| Burundi: T18 | Experimental | Not described Receives: Other: Tubaramure (Burundi) |
| Burundi: Control | No intervention | Not described |
| Guatemala: PROCOMIDA | Experimental | Not described Receives: Other: Procomida (Guatemala) |
| Guatemala: no family ration | Experimental | Not described Receives: Other: Procomida (Guatemala) |
| Guatemala: LNS | Experimental | Not described Receives: Other: Procomida (Guatemala) |
| Guatemala: Sprinkles | Experimental | Not described Receives: Other: Procomida (Guatemala) |
| Guatemala: reduced family ration | Experimental | Not described Receives: Other: Procomida (Guatemala) |
| Guatemala: control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
child nutritional status
Measured: Burundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
Secondary outcomes (6)
household food security
Measured: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
household food and non-food consumption
Measured: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
maternal knowledge on infant and young child feeding (IYCF) and health
Measured: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
attitudes towards IYCF and health
Measured: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
morbidity
Measured: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
health care seeking behavior
Measured: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16,895 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Nutrition Technical Assistance Project 2 of the Academy of Educational Development, United States Agency for International Development (USAID), Catholic Relieve Services-Burundi, Mercy Corps-Guatemala
- Responsible party
- Sponsor
- Investigators
- Marie Ruel, PhD, Principal investigator, IFPRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072279
- Sponsor's protocol ID
- 4001-IFPRI-00
- Status last verified
- Jan 2013
- First submitted
- 17 Feb 2010
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Loechl CU, Menon P, Arimond M, Ruel MT, Pelto G, Habicht JP, Michaud L. Using programme theory to assess the feasibility of delivering micronutrient Sprinkles through a food-assisted maternal and child health and nutrition programme in rural Haiti. Matern Child Nutr. 2009 Jan;5(1):33-48. doi: 10.1111/j.1740-8709.2008.00154.x.
PubMed 19161543Menon P, Mbuya M, Habicht JP, Pelto G, Loechl CU, Ruel MT. Assessing supervisory and motivational factors in the context of a program evaluation in rural Haiti. J Nutr. 2008 Mar;138(3):634-7. doi: 10.1093/jn/138.3.634.
PubMed 18287379Ruel MT, Menon P, Habicht JP, Loechl C, Bergeron G, Pelto G, Arimond M, Maluccio J, Michaud L, Hankebo B. Age-based preventive targeting of food assistance and behaviour change and communication for reduction of childhood undernutrition in Haiti: a cluster randomised trial. Lancet. 2008 Feb 16;371(9612):588-95. doi: 10.1016/S0140-6736(08)60271-8.
PubMed 18280329Menon P, Ruel MT, Loechl CU, Arimond M, Habicht JP, Pelto G, Michaud L. Micronutrient Sprinkles reduce anemia among 9- to 24-mo-old children when delivered through an integrated health and nutrition program in rural Haiti. J Nutr. 2007 Apr;137(4):1023-30. doi: 10.1093/jn/137.4.1023.
PubMed 17374671Menon P, Ruel MT, Loechl C, Pelto G. From research to program design: use of formative research in Haiti to develop a behavior change communication program to prevent malnutrition. Food Nutr Bull. 2005 Jun;26(2):241-2. doi: 10.1177/156482650502600210. No abstract available.
PubMed 16060227Ruel MT, Menon P, Loechl C, Pelto G. Donated fortified cereal blends improve the nutrient density of traditional complementary foods in Haiti, but iron and zinc gaps remain for infants. Food Nutr Bull. 2004 Dec;25(4):361-76. doi: 10.1177/156482650402500406.
PubMed 15646314Leroy JL, K Olney D, Bliznashka L, Ruel M. Tubaramure, a Food-Assisted Maternal and Child Health and Nutrition Program in Burundi, Increased Household Food Security and Energy and Micronutrient Consumption, and Maternal and Child Dietary Diversity: A Cluster-Randomized Controlled Trial. J Nutr. 2020 Apr 1;150(4):945-957. doi: 10.1093/jn/nxz295.
PubMed 31858128Leroy JL, Olney DK, Ruel MT. PROCOMIDA, a Food-Assisted Maternal and Child Health and Nutrition Program, Contributes to Postpartum Weight Retention in Guatemala: A Cluster-Randomized Controlled Intervention Trial. J Nutr. 2019 Dec 1;149(12):2219-2227. doi: 10.1093/jn/nxz175.
PubMed 31373374Olney DK, Leroy JL, Bliznashka L, Ruel MT. A Multisectoral Food-Assisted Maternal and Child Health and Nutrition Program Targeted to Women and Children in the First 1000 Days Increases Attainment of Language and Motor Milestones among Young Burundian Children. J Nutr. 2019 Oct 1;149(10):1833-1842. doi: 10.1093/jn/nxz133.
PubMed 31268132Olney DK, Leroy J, Bliznashka L, Ruel MT. PROCOMIDA, a Food-Assisted Maternal and Child Health and Nutrition Program, Reduces Child Stunting in Guatemala: A Cluster-Randomized Controlled Intervention Trial. J Nutr. 2018 Sep 1;148(9):1493-1505. doi: 10.1093/jn/nxy138.
PubMed 30184223Leroy JL, Olney D, Ruel M. Tubaramure, a Food-Assisted Integrated Health and Nutrition Program, Reduces Child Stunting in Burundi: A Cluster-Randomized Controlled Intervention Trial. J Nutr. 2018 Mar 1;148(3):445-452. doi: 10.1093/jn/nxx063.
PubMed 29546306Leroy JL, Olney D, Ruel M. Tubaramure, a Food-Assisted Integrated Health and Nutrition Program in Burundi, Increases Maternal and Child Hemoglobin Concentrations and Reduces Anemia: A Theory-Based Cluster-Randomized Controlled Intervention Trial. J Nutr. 2016 Aug;146(8):1601-8. doi: 10.3945/jn.115.227462. Epub 2016 Jul 13.
PubMed 27412269
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening and Evaluating the "Preventing Malnutrition in Children Under Two Years of Age Approach" (PM2A) in Guatemala and Burundi
- ClinicalTrials.gov ID
- NCT01072279
- Acronym / sponsor ID
- 4001-IFPRI-00
- Conditions
- Malnutrition
- Keywords
- Malnutrition;, Infant nutrition;, Fortified food, Linear growth, Cluster randomized controlled trials, Effectiveness, Impact evaluation studies, Burundi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16,895 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- Food and Nutrition Technical Assistance Project 2 of the Academy of Educational Development, United States Agency for International Development (USAID), Catholic Relieve Services-Burundi, Mercy Corps-Guatemala
- Study start
- Apr 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 22 Feb 2010 (estimated)
- 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.
A study conducted by IFPRI in Haiti provided the first programmatic evidence, using a cluster randomized evaluation design, that preventing child undernutrition in children under two years of age (PM2A) through an integrated program providing food rations, BCC and preventive health and nutrition services is both feasible and highly effective. The study's principal aim was to compare a newly designed preventive approach with the traditional (recuperative) food assisted MCHN program approach, and therefore included only two comparison groups: one group of communities that was randomly assigned to the preventive approach and another group assigned to the recuperative approach. For logistical and financial reasons, the study did not include a randomized control group receiving no intervention.
The Haiti study design was well-suited to achieve its main goal - i.e. to test whether the preventive approach was more effective than the recuperative approach at preventing child undernutrition - but it left a number of questions unanswered.
The present study will address several of these questions, which will allow to further refine the PM2A approach, facilitate its replication in different contexts, and maximize its impact and cost-effectiveness in future programming. The study will be conducted in Guatemala and Burundi. The key research objectives are:
- Impact and cost effectiveness: Assess the impact and cost effectiveness of PM2A on child nutritional status.
- Optimal composition and size of food rations in PM2A: Assess the differential and absolute impact of varying the size and types of foods incorporated in the food ration of the PM2A. More specifically, assess the differential effect of different sizes of family food rations, and assess the impact of substituting the individual food ration with new micronutrient-rich products such as lipid-based nutrient supplements (LNS) or micronutrient Sprinkles.
- Optimal timing and duration of PM2A: Assess the differential and absolute impact of varying the timing and duration of exposure to PM2A on child nutritional status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Burundi: T24 | Experimental | Other: Tubaramure (Burundi) |
| Burundi: TNFP | Experimental | Other: Tubaramure (Burundi) |
| Burundi: T18 | Experimental | Other: Tubaramure (Burundi) |
| Burundi: Control | No intervention | – |
| Guatemala: PROCOMIDA | Experimental | Other: Procomida (Guatemala) |
| Guatemala: no family ration | Experimental | Other: Procomida (Guatemala) |
| Guatemala: LNS | Experimental | Other: Procomida (Guatemala) |
| Guatemala: Sprinkles | Experimental | Other: Procomida (Guatemala) |
| Guatemala: reduced family ration | Experimental | Other: Procomida (Guatemala) |
| Guatemala: control | No intervention | – |
Who may qualify
- Ages
- Up to 42 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Guatemala: pregnant mothers and subsequently their born children up to the age of 24 months;
- Burundi: cross-sectional study: children 0 to 42 of age.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Tubaramure (Burundi)Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices | Other | Burundi: T18, Burundi: T24, Burundi: TNFP |
| Procomida (Guatemala)Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices | Other | Guatemala: LNS, Guatemala: PROCOMIDA, Guatemala: Sprinkles, Guatemala: no family ration, Guatemala: reduced family ration |
Primary outcome
child nutritional status
Time frame: Burundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
6 secondary outcomes
household food security
Time frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
household food and non-food consumption
Time frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
maternal knowledge on infant and young child feeding (IYCF) and health
Time frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
attitudes towards IYCF and health
Time frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
morbidity
Time frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
health care seeking behavior
Time frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
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 25 Feb 2016.
- Background: PubMed 19161543Loechl CU, Menon P, Arimond M, Ruel MT, Pelto G, Habicht JP, Michaud L. Using programme theory to assess the feasibility of delivering micronutrient Sprinkles through a food-assisted maternal and child health and nutrition programme in rural Haiti. Matern Child Nutr. 2009 Jan;5(1):33-48. doi: 10.1111/j.1740-8709.2008.00154.x.
- Background: PubMed 18287379Menon P, Mbuya M, Habicht JP, Pelto G, Loechl CU, Ruel MT. Assessing supervisory and motivational factors in the context of a program evaluation in rural Haiti. J Nutr. 2008 Mar;138(3):634-7. doi: 10.1093/jn/138.3.634.
- Background: PubMed 18280329Ruel MT, Menon P, Habicht JP, Loechl C, Bergeron G, Pelto G, Arimond M, Maluccio J, Michaud L, Hankebo B. Age-based preventive targeting of food assistance and behaviour change and communication for reduction of childhood undernutrition in Haiti: a cluster randomised trial. Lancet. 2008 Feb 16;371(9612):588-95. doi: 10.1016/S0140-6736(08)60271-8.
- Background: PubMed 17374671Menon P, Ruel MT, Loechl CU, Arimond M, Habicht JP, Pelto G, Michaud L. Micronutrient Sprinkles reduce anemia among 9- to 24-mo-old children when delivered through an integrated health and nutrition program in rural Haiti. J Nutr. 2007 Apr;137(4):1023-30. doi: 10.1093/jn/137.4.1023.
- Background: PubMed 16060227Menon P, Ruel MT, Loechl C, Pelto G. From research to program design: use of formative research in Haiti to develop a behavior change communication program to prevent malnutrition. Food Nutr Bull. 2005 Jun;26(2):241-2. doi: 10.1177/156482650502600210. No abstract available.
- Background: PubMed 15646314Ruel MT, Menon P, Loechl C, Pelto G. Donated fortified cereal blends improve the nutrient density of traditional complementary foods in Haiti, but iron and zinc gaps remain for infants. Food Nutr Bull. 2004 Dec;25(4):361-76. doi: 10.1177/156482650402500406.
- Derived from this study: PubMed 31858128Leroy JL, K Olney D, Bliznashka L, Ruel M. Tubaramure, a Food-Assisted Maternal and Child Health and Nutrition Program in Burundi, Increased Household Food Security and Energy and Micronutrient Consumption, and Maternal and Child Dietary Diversity: A Cluster-Randomized Controlled Trial. J Nutr. 2020 Apr 1;150(4):945-957. doi: 10.1093/jn/nxz295.
- Derived from this study: PubMed 31373374Leroy JL, Olney DK, Ruel MT. PROCOMIDA, a Food-Assisted Maternal and Child Health and Nutrition Program, Contributes to Postpartum Weight Retention in Guatemala: A Cluster-Randomized Controlled Intervention Trial. J Nutr. 2019 Dec 1;149(12):2219-2227. doi: 10.1093/jn/nxz175.
- Derived from this study: PubMed 31268132Olney DK, Leroy JL, Bliznashka L, Ruel MT. A Multisectoral Food-Assisted Maternal and Child Health and Nutrition Program Targeted to Women and Children in the First 1000 Days Increases Attainment of Language and Motor Milestones among Young Burundian Children. J Nutr. 2019 Oct 1;149(10):1833-1842. doi: 10.1093/jn/nxz133.
- Derived from this study: PubMed 30184223Olney DK, Leroy J, Bliznashka L, Ruel MT. PROCOMIDA, a Food-Assisted Maternal and Child Health and Nutrition Program, Reduces Child Stunting in Guatemala: A Cluster-Randomized Controlled Intervention Trial. J Nutr. 2018 Sep 1;148(9):1493-1505. doi: 10.1093/jn/nxy138.
- Derived from this study: PubMed 29546306Leroy JL, Olney D, Ruel M. Tubaramure, a Food-Assisted Integrated Health and Nutrition Program, Reduces Child Stunting in Burundi: A Cluster-Randomized Controlled Intervention Trial. J Nutr. 2018 Mar 1;148(3):445-452. doi: 10.1093/jn/nxx063.
- Derived from this study: PubMed 27412269Leroy JL, Olney D, Ruel M. Tubaramure, a Food-Assisted Integrated Health and Nutrition Program in Burundi, Increases Maternal and Child Hemoglobin Concentrations and Reduces Anemia: A Theory-Based Cluster-Randomized Controlled Intervention Trial. J Nutr. 2016 Aug;146(8):1601-8. doi: 10.3945/jn.115.227462. Epub 2016 Jul 13.
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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.
Marie Ruel, PhD principal investigator
IFPRI
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tubaramure (Burundi) and Procomida (Guatemala) in people with Malnutrition, run by International Food Policy Research Institute at 2 sites in 2 countries.
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 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burundi, Guatemala. 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?
child nutritional status (time frame: Burundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo). 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 NCT01072279, which also lists 12 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 25 Feb 2016.