Back to resultsLet's be Well Red: Efficacy of Gudness Bars in Improving the Hemoglobin and Hematocrit Levels of Anemic Subjects (LBWR)
Primary Purpose
Treatment and Prevention of Anemia After Administration of Gudness Nutrition Bar
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Education plus Gudness Nutritional Bar
Education
Sponsored by
About this trial
This is an interventional prevention trial for Treatment and Prevention of Anemia After Administration of Gudness Nutrition Bar focused on measuring anemia
Eligibility Criteria
Inclusion Criteria:
- Female
- Ages 18-35 years age
Exclusion Criteria:
- Known allergy towards nuts.
Sites / Locations
- Lets Be Well Red
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Education plus Gudness Nutritional Bar
Education with no nutrition bar
Arm Description
Subjects will receive education about anemia and will consume Gudness Nutrition bars for 3 months
Subjects will receive education about anemia but will not receive nutrition bar
Outcomes
Primary Outcome Measures
Hemoglobin level
Measure hemoglobin levels before and after administration of Gudness nutrition bar.
Hematocrit level
Measure Hematocrit levels before and after administration of Gudness nutrition bar.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02032615
Brief Title
Let's be Well Red: Efficacy of Gudness Bars in Improving the Hemoglobin and Hematocrit Levels of Anemic Subjects
Acronym
LBWR
Official Title
Let's Be Well Red (LBWR)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment and Prevention of Anemia After Administration of Gudness Nutrition Bar
Keywords
anemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
358 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education plus Gudness Nutritional Bar
Arm Type
Active Comparator
Arm Description
Subjects will receive education about anemia and will consume Gudness Nutrition bars for 3 months
Arm Title
Education with no nutrition bar
Arm Type
Placebo Comparator
Arm Description
Subjects will receive education about anemia but will not receive nutrition bar
Intervention Type
Dietary Supplement
Intervention Name(s)
Education plus Gudness Nutritional Bar
Intervention Type
Other
Intervention Name(s)
Education
Other Intervention Name(s)
Education about Anemia
Primary Outcome Measure Information:
Title
Hemoglobin level
Description
Measure hemoglobin levels before and after administration of Gudness nutrition bar.
Time Frame
3 months
Title
Hematocrit level
Description
Measure Hematocrit levels before and after administration of Gudness nutrition bar.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female
Ages 18-35 years age
Exclusion Criteria:
Known allergy towards nuts.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Clements, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lets Be Well Red
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400092
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
28100507
Citation
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.
Results Reference
derived
Learn more about this trial
Let's be Well Red: Efficacy of Gudness Bars in Improving the Hemoglobin and Hematocrit Levels of Anemic Subjects
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