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