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
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Tracking Information | |||||||
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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 |
Improvement in Hemoglobin status [ Time Frame: 3 months ] Comparison of Hb levels pre and post intervention
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures ICMJE |
Changes in BMI [ Time Frame: 5 months ] Changes in BMI after improvement in Hb status
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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. |
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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 |
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Condition ICMJE | Anemia, Iron Deficiency | ||||||
Intervention ICMJE | Dietary Supplement: Dried Moringa oleifera leaves | ||||||
Study Arms ICMJE |
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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. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Madeeha Munir, Kinnaird College for Women | ||||||
Study Sponsor ICMJE | Kinnaird College for Women | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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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 |