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Impact of Dried Moringa Oleifera Leaves in Enhancing Hemoglobin Status

Primary Purpose

Anemia, Iron Deficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dried Moringa oleifera leaves
Sponsored by
Kinnaird College for Women
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anemia, Iron Deficiency focused on measuring Hb, Anemia,

Eligibility Criteria

13 Years - 30 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Reproductive aged females (13-30 years)

Exclusion Criteria:

  • pregnant and Lactating women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group A (Below 18 years)

    Group B (Above 18)

    Arm Description

    Dried Moringa oleifera leaves (15g/recipe)

    Dried Moringa oleifera leaves (15g/recipe)

    Outcomes

    Primary Outcome Measures

    Improvement in Hemoglobin status
    Comparison of Hb levels pre and post intervention

    Secondary Outcome Measures

    Changes in BMI
    Changes in BMI after improvement in Hb status

    Full Information

    First Posted
    April 19, 2018
    Last Updated
    May 1, 2018
    Sponsor
    Kinnaird College for Women
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03514472
    Brief Title
    Impact of Dried Moringa Oleifera Leaves in Enhancing Hemoglobin Status
    Official Title
    Impact of Dried Moringa Oleifera Leaves as Value Added Supplement in Enhancing Hemoglobin Status of Reproductive Aged Females of Low Socio-economic Group
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (Actual)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kinnaird College for Women

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This research project is aimed at combating the nutritional deficiencies (Iron deficiency anemia) of reproductive aged females belonging to the underprivileged group of the society. Since anemia is one of the causes of still child-birth, preterm and low birth weight babies causing cognitive disabilities during the later years of life, So, it needs to be treated on priority bases.
    Detailed Description
    Mal-nutrition is a significant problem in the developing world, with serious consequences for human health and socio-economic development. It is estimated that over 43% women of reproductive age suffer from anemia. In Pakistan, about 35% non-pregnant and 51% pregnant women are suffering from anemia. Prevention and control against anemia rely on iron supplementation and food fortification on large scale. Both these methods are not affordable and feasible for poor people. Previous studies have shown that about 97% females do not meet their iron requirements. The possible reason to this can be iron losses from body including menstruation. To overcome these problems, culturally accepted, inexpensive and modified recipes were used to supply iron with addition of Moringa oleifera leaves (rich and cheap source of iron). In the study 34 of ages between 13-30 years were selected (excluding pregnant and lactating women) and were intervened with value added supplement " Moringa oleifera" for a period of three months. These recipes were made part of the diet by giving a dose of three meals per day on regular basis. Each recipe contained about 15 g of Dried Moringa powder. After the intervention, out of total 34, 3 females achieved normal Hb level of 12 g/dl. Overall, 94% cases of the study showed improvement of 1.8 g/dl (on average) in Hb level after intervention. There was a significant increase in blood Hb level (p<0.000) and both the var5iables were strongly and positively correlated (0.928). Variables of age and levels of education were weakly but significantly related to each other (p<0.001) in improving Hb after intervention. Females with higher levels of education showed better response towards intervention. After intervention with Moringa oleifera, an average increase of 1.5 g/dl in Hb was observed in the entire population whereas, members of Group B (ages above 18) showed more increase of 14.96% in their Hb level as compared to members of Group A (ages below 18) showing an increase of 12.96% in Hb level.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia, Iron Deficiency
    Keywords
    Hb, Anemia,

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    In the study 34 of ages between 13-30 years divided into 2 age groups (below and above 18) were selected (excluding pregnant and lactating women) and were intervened with value added supplement " Moringa oleifera" for a period of three months.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A (Below 18 years)
    Arm Type
    Active Comparator
    Arm Description
    Dried Moringa oleifera leaves (15g/recipe)
    Arm Title
    Group B (Above 18)
    Arm Type
    Active Comparator
    Arm Description
    Dried Moringa oleifera leaves (15g/recipe)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Dried Moringa oleifera leaves
    Primary Outcome Measure Information:
    Title
    Improvement in Hemoglobin status
    Description
    Comparison of Hb levels pre and post intervention
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Changes in BMI
    Description
    Changes in BMI after improvement in Hb status
    Time Frame
    5 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Reproductive aged females ( those who are capable of bearing a child)
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Reproductive aged females (13-30 years) Exclusion Criteria: pregnant and Lactating women
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Madeeha Munir, M.Phil
    Organizational Affiliation
    Kinnaird College for Women
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    14558778
    Citation
    Anwar F, Bhanger MI. Analytical characterization of Moringa oleifera seed oil grown in temperate regions of Pakistan. J Agric Food Chem. 2003 Oct 22;51(22):6558-63. doi: 10.1021/jf0209894.
    Results Reference
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    Impact of Dried Moringa Oleifera Leaves in Enhancing Hemoglobin Status

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