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

NCT ID: NCT02032615

Last Updated: 2016-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

358 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Treatment and Prevention of Anemia After Administration of Gudness Nutrition Bar

Keywords

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anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Education plus Gudness Nutritional Bar

Subjects will receive education about anemia and will consume Gudness Nutrition bars for 3 months

Group Type ACTIVE_COMPARATOR

Education plus Gudness Nutritional Bar

Intervention Type DIETARY_SUPPLEMENT

Education with no nutrition bar

Subjects will receive education about anemia but will not receive nutrition bar

Group Type PLACEBO_COMPARATOR

Education

Intervention Type OTHER

Interventions

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Education plus Gudness Nutritional Bar

Intervention Type DIETARY_SUPPLEMENT

Education

Intervention Type OTHER

Other Intervention Names

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Education about Anemia

Eligibility Criteria

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Inclusion Criteria

* Female
* Ages 18-35 years age

Exclusion Criteria

* Known allergy towards nuts.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dennis Clements, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Lets Be Well Red

Mumbai, Maharashtra, India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED
PMID: 28100507 (View on PubMed)

Other Identifiers

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Pro00051046

Identifier Type: -

Identifier Source: org_study_id