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Let's be Well Red: Efficacy of Gudness Bars in Improving the Hemoglobin and Hematocrit Levels of Anemic Subjects (LBWR)

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ClinicalTrials.gov Identifier: NCT02032615
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
Duke University

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.


Condition or disease Intervention/treatment Phase
Treatment and Prevention of Anemia After Administration of Gudness Nutrition Bar Dietary Supplement: Education plus Gudness Nutritional Bar Other: Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Let's Be Well Red (LBWR)
Study Start Date : April 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Active Comparator: Education plus Gudness Nutritional Bar
Subjects will receive education about anemia and will consume Gudness Nutrition bars for 3 months
Dietary Supplement: Education plus Gudness Nutritional Bar
Placebo Comparator: Education with no nutrition bar
Subjects will receive education about anemia but will not receive nutrition bar
Other: Education
Other Name: Education about Anemia




Primary Outcome Measures :
  1. Hemoglobin level [ Time Frame: 3 months ]
    Measure hemoglobin levels before and after administration of Gudness nutrition bar.

  2. Hematocrit level [ Time Frame: 3 months ]
    Measure Hematocrit levels before and after administration of Gudness nutrition bar.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Ages 18-35 years age

Exclusion Criteria:

  • Known allergy towards nuts.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032615


Locations
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India
Lets Be Well Red
Mumbai, Maharashtra, India, 400092
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Dennis Clements, MD Duke University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02032615     History of Changes
Other Study ID Numbers: Pro00051046
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: August 2015
Keywords provided by Duke University:
anemia
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases