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Impact of Dried Moringa Oleifera Leaves in Enhancing Hemoglobin Status

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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

Tracking Information
First Submitted Date  ICMJE April 19, 2018
First Posted Date  ICMJE May 2, 2018
Last Update Posted Date May 2, 2018
Actual Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
Improvement in Hemoglobin status [ Time Frame: 3 months ]
Comparison of Hb levels pre and post intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
Changes in BMI [ Time Frame: 5 months ]
Changes in BMI after improvement in Hb status
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Dried Moringa Oleifera Leaves in Enhancing Hemoglobin Status
Official Title  ICMJE Impact of Dried Moringa Oleifera Leaves as Value Added Supplement in Enhancing Hemoglobin Status of Reproductive Aged Females of Low Socio-economic Group
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Anemia, Iron Deficiency
Intervention  ICMJE Dietary Supplement: Dried Moringa oleifera leaves
Study Arms  ICMJE
  • Active Comparator: Group A (Below 18 years)
    Dried Moringa oleifera leaves (15g/recipe)
    Intervention: Dietary Supplement: Dried Moringa oleifera leaves
  • Active Comparator: Group B (Above 18)
    Dried Moringa oleifera leaves (15g/recipe)
    Intervention: Dietary Supplement: Dried Moringa oleifera leaves
Publications * ACC/SCN. (1998). Challenges for the 21 st Century: A Gender perspective on the Nutrition through the Life Cycle. Geneva: ACC/SCN Secretariat c/o WHO. Anwar, F., & Bhanger, M. I. (2003). Analytical characterization of Moringa oleifera seed oil grown in temperate regions of Pakistan . Journal of Agricultural and Food Chemistry, 51, 6558-6563.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2018)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Reproductive aged females (13-30 years)

Exclusion Criteria:

  • pregnant and Lactating women
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Reproductive aged females ( those who are capable of bearing a child)
Ages  ICMJE 13 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03514472
Other Study ID Numbers  ICMJE MMunir
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Madeeha Munir, Kinnaird College for Women
Study Sponsor  ICMJE Kinnaird College for Women
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Madeeha Munir, M.Phil Kinnaird College for Women
PRS Account Kinnaird College for Women
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP