- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03514472
Impact of Dried Moringa Oleifera Leaves in Enhancing Hemoglobin Status
Impact of Dried Moringa Oleifera Leaves as Value Added Supplement in Enhancing Hemoglobin Status of Reproductive Aged Females of Low Socio-economic Group
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Reproductive aged females (13-30 years)
Exclusion Criteria:
- pregnant and Lactating women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A (Below 18 years)
Dried Moringa oleifera leaves (15g/recipe)
|
|
Active Comparator: Group B (Above 18)
Dried Moringa oleifera leaves (15g/recipe)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in Hemoglobin status
Time Frame: 3 months
|
Comparison of Hb levels pre and post intervention
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in BMI
Time Frame: 5 months
|
Changes in BMI after improvement in Hb status
|
5 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Madeeha Munir, M.Phil, Kinnaird College for Women
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMunir
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anemia, Iron Deficiency
-
Pennington Biomedical Research CenterRecruitingIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia TreatmentUnited States
-
Children's Hospital Los AngelesNot yet recruitingAnemia | Iron Deficiency Anemia | Anemia, Iron Deficiency | IDA - Iron Deficiency AnemiaUnited States
-
King's CollegeCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)United States
-
Arrowhead Regional Medical CenterRecruitingIron Deficiency Anemia of PregnancyUnited States
-
Swiss Federal Institute of TechnologyUnited States Agency for International Development (USAID); Quadram Institute... and other collaboratorsCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)Peru
-
Luzerner KantonsspitalRecruitingIron Deficiency Anemia | Iron Deficiency Anemia Treatment | Iron DeficienciesSwitzerland
-
Children's Hospital Los AngelesWithdrawnAnemia | Iron-deficiency Anemia | Healthy ControlsUnited States
-
Baylor College of MedicineNational Heart, Lung, and Blood Institute (NHLBI)CompletedIron-deficiency | Iron Deficiency AnemiaUnited States
-
Iowa State UniversityCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia Treatment | Iron Deficiency Anaemia Due to Dietary CausesUnited States
-
Société des Produits Nestlé (SPN)CompletedIron-deficiency | Anemia | Iron Deficiency AnemiaPhilippines
Clinical Trials on Dried Moringa oleifera leaves
-
Suzanna L AttiaFogarty International Center of the National Institute of HealthCompletedMalnutrition | Wasting | Growth FailureKenya
-
University of KentuckyUniversity of IdahoRecruiting
-
Universitas Sebelas MaretCompletedRheumatoid ArthritisIndonesia
-
University of MauritiusUnknown
-
Chulalongkorn UniversityCompletedPostpartum WomenThailand
-
Cairo UniversityRecruiting
-
Appalachian State UniversityNorth Carolina Agriculture & Technical State UniversityCompletedPostmenopausal Osteoporosis | Osteoporosis, OsteopeniaUnited States
-
Ospital ng Maynila Medical CenterCompleted
-
Mbarara University of Science and TechnologyANAMEDCompleted
-
Aga Khan UniversityMuhammad Safdar AliUnknown