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Impact of Dried Moringa Oleifera Leaves in Enhancing Hemoglobin Status

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514472
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Madeeha Munir, Kinnaird College for Women

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anemia, Iron Deficiency Dietary Supplement: Dried Moringa oleifera leaves Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Supportive Care
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
Actual Study Start Date : January 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group A (Below 18 years)
Dried Moringa oleifera leaves (15g/recipe)
 Dietary Supplement: Dried Moringa oleifera leaves
Active Comparator: Group B (Above 18)
Dried Moringa oleifera leaves (15g/recipe)
 Dietary Supplement: Dried Moringa oleifera leaves


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in Hemoglobin status [ Time Frame: 3 months ]
    Comparison of Hb levels pre and post intervention


Secondary Outcome Measures :
  1. Changes in BMI [ Time Frame: 5 months ]
    Changes in BMI after improvement in Hb status


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Reproductive aged females ( those who are capable of bearing a child)
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Reproductive aged females (13-30 years)

Exclusion Criteria:

  • pregnant and Lactating women
Contacts and Locations
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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): NCT03514472


Sponsors and Collaborators
Kinnaird College for Women
Investigators
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Principal Investigator: Madeeha Munir, M.Phil Kinnaird College for Women
More Information
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Publications:

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Responsible Party: Madeeha Munir, Former Lecturer Minhaj University, Kinnaird College for Women
ClinicalTrials.gov Identifier: NCT03514472    
Other Study ID Numbers: MMunir
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Madeeha Munir, Kinnaird College for Women:
Hb, Anemia,
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Iron Deficiencies
Anemia
Hematologic Diseases
 Iron Metabolism Disorders
Metabolic Diseases
Anemia, Hypochromic