Treatment and Prevention of Anemia After Administration of Gudness Nutrition BarLBWRNCT02032615
Let's be Well Red: Efficacy of Gudness Bars in Improving the Hemoglobin and Hematocrit Levels of Anemic Subjects
A study testing Education plus Gudness Nutritional Bar and Education in people with Treatment and Prevention of Anemia After Administration of Gudness Nutrition Bar, run by Duke University at 1 site in India.
Trial summary
To test the efficacy of Gudness Bars in improving the hemoglobin and hematocrit levels of anemic subjects longitudinally. To quantify the demographics of subjects attending anemia testing camps through LBWR and to explore correlations with the demographics data. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Treatment and Prevention of Anemia After Administration of Gudness Nutrition Bar
- What is being tested?
- Education plus Gudness Nutritional Bar and Education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 358 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2014to Aug 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Ages 18-35 years age
Who cannot join
- Known allergy towards nuts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Let's Be Well Red (LBWR)
To test the efficacy of Gudness Bars in improving the hemoglobin and hematocrit levels of anemic subjects longitudinally.
To quantify the demographics of subjects attending anemia testing camps through LBWR and to explore correlations with the demographics data.
- Being tested
- Education plus Gudness Nutritional Bar, Education
- Keywords
- anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education plus Gudness Nutritional BarDietary supplement
EducationOther
Also called Education about Anemia
| Study group | Role | What they receive |
|---|---|---|
| Education plus Gudness Nutritional Bar | Active comparator | Subjects will receive education about anemia and will consume Gudness Nutrition bars for 3 months Receives: Dietary Supplement: Education plus Gudness Nutritional Bar |
| Education with no nutrition bar | Placebo comparator | Subjects will receive education about anemia but will not receive nutrition bar Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin level
Measure hemoglobin levels before and after administration of Gudness nutrition bar.
Measured: 3 months
Hematocrit level
Measure Hematocrit levels before and after administration of Gudness nutrition bar.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment and Prevention of Anemia After Administration of Gudness Nutrition BarStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis Clements, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032615
- Sponsor's protocol ID
- Pro00051046
- Acronym
- LBWR
- Status last verified
- Aug 2015
- First submitted
- 8 Jan 2014
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mehta R, Platt AC, Sun X, Desai M, Clements D, Turner EL. Efficacy of iron-supplement bars to reduce anemia in urban Indian women: a cluster-randomized controlled trial. Am J Clin Nutr. 2017 Mar;105(3):746-757. doi: 10.3945/ajcn.115.127555. Epub 2017 Jan 18.
PubMed 28100507
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Let's Be Well Red (LBWR)
- ClinicalTrials.gov ID
- NCT02032615
- Acronym / sponsor ID
- LBWR / Pro00051046
- Keywords
- anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Jan 2014 (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.
To test the efficacy of Gudness Bars in improving the hemoglobin and hematocrit levels of anemic subjects longitudinally.
To quantify the demographics of subjects attending anemia testing camps through LBWR and to explore correlations with the demographics data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education plus Gudness Nutritional Bar | Active comparator | Dietary Supplement: Education plus Gudness Nutritional BarSubjects will receive education about anemia and will consume Gudness Nutrition bars for 3 months |
| Education with no nutrition bar | Placebo comparator | Other: EducationSubjects will receive education about anemia but will not receive nutrition bar |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female
- Ages 18-35 years age
Key exclusion criteria (1 listed)
- Known allergy towards nuts.
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 |
|---|---|---|
| Education plus Gudness Nutritional Bar | Dietary supplement | Education plus Gudness Nutritional Bar |
| EducationAlso: Education about Anemia | Other | Education with no nutrition bar |
Primary outcome
Hemoglobin level
Time frame: 3 months
Measure hemoglobin levels before and after administration of Gudness nutrition bar.
Hematocrit level
Time frame: 3 months
Measure Hematocrit levels before and after administration of Gudness nutrition bar.
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 Nov 2016.
- Derived from this study: PubMed 28100507Mehta R, Platt AC, Sun X, Desai M, Clements D, Turner EL. Efficacy of iron-supplement bars to reduce anemia in urban Indian women: a cluster-randomized controlled trial. Am J Clin Nutr. 2017 Mar;105(3):746-757. doi: 10.3945/ajcn.115.127555. Epub 2017 Jan 18.
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.
Dennis Clements, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education plus Gudness Nutritional Bar and Education in people with Treatment and Prevention of Anemia After Administration of Gudness Nutrition Bar, run by Duke University at 1 site in India.
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 Nov 2016. 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 India. 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.
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?
Hemoglobin level (time frame: 3 months). 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 NCT02032615, which also lists 1 linked publication.
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 Nov 2016.