Impact of Dried Moringa Oleifera Leaves in Enhancing Hemoglobin Status

• ClinicalTrials.gov Identifier: NCT03514472
• Recruitment Status: Completed
• First Posted: May 2, 2018
• Last Update Posted: May 2, 2018
• Sponsor: Kinnaird College for Women
• Information provided by (Responsible Party): Madeeha Munir, Kinnaird College for Women

Tracking Information

• First Submitted Date: April 19, 2018
• First Posted Date: May 2, 2018
• Last Update Posted Date: May 2, 2018
• Actual Study Start Date: January 2013
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 1, 2018)

Improvement in Hemoglobin status [ Time Frame: 3 months ]

Comparison of Hb levels pre and post intervention

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 1, 2018)

Changes in BMI [ Time Frame: 5 months ]

Changes in BMI after improvement in Hb status

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Anemia, Iron Deficiency
• Intervention: Dietary Supplement: Dried Moringa oleifera leaves

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 1, 2018): 34
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 2014
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Reproductive aged females (13-30 years)

Exclusion Criteria:

• pregnant and Lactating women

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Reproductive aged females ( those who are capable of bearing a child)

• Ages: 13 Years to 30 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03514472
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Madeeha Munir, Kinnaird College for Women
• Study Sponsor: Kinnaird College for Women
• Collaborators: Not Provided

Investigators

• Principal Investigator: Madeeha Munir, M.Phil; Kinnaird College for Women

• PRS Account: Kinnaird College for Women
• Verification Date: May 2018