Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03514472
Other study ID # MMunir
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2013
Est. completion date April 2014

Study information

Verified date May 2018
Source Kinnaird College for Women
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date April 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Female
Age group 13 Years to 30 Years
Eligibility Inclusion Criteria:

- Reproductive aged females (13-30 years)

Exclusion Criteria:

- pregnant and Lactating women

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Dried Moringa oleifera leaves


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kinnaird College for Women

References & Publications (1)

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in Hemoglobin status Comparison of Hb levels pre and post intervention 3 months
Secondary Changes in BMI Changes in BMI after improvement in Hb status 5 months
See also
  Status Clinical Trial Phase
Completed NCT04435574 - Lactoferrin for Treatment of Iron Deficiency Anemia. Phase 4
Not yet recruiting NCT05467319 - Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS Phase 3
Not yet recruiting NCT05050851 - Nutritional Parameters and Other Risk Factors Affecting Severity of Pneumonia in Children Under Five Years in Upper Egypt
Recruiting NCT04278651 - Early Antenatal Support for Iron Deficiency Anemia Phase 4
Recruiting NCT04626414 - Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers Phase 1
Withdrawn NCT03800446 - Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood N/A
Recruiting NCT05304442 - IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department Phase 3
Enrolling by invitation NCT03897673 - Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas N/A
Completed NCT05047211 - Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia Phase 4
Not yet recruiting NCT06061393 - Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency Anemia Phase 4
Completed NCT05190263 - Quality Assurance on Anemia Management in Patients With Solid Tumors and Malignant Lymphoma
Completed NCT03318055 - Prevalence of Hyperglycemia and Anaemia in Elective Surgical Patients
Completed NCT04631679 - Investigation of the Wash-out Effect of Intravenous Iron by Cell Savers (WASH-OUT)
Recruiting NCT05225545 - Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis Phase 3
Recruiting NCT03347513 - Eradication of H-pylori in Pregnancy and Its Effect on Iron Replacement Therapy? Phase 4
Recruiting NCT04708665 - Iron Deficiency Anemia and Non-iron Deficiency Anemia in Pregnancy in India
Completed NCT02404012 - Iron Supplement to Improve Iron Status Following Bariatric Surgery N/A
Completed NCT04137354 - Iron and Vitamin A in School Children N/A
Not yet recruiting NCT06096103 - A Clinical Study to Check the Safety and Effectiveness of Botanical Extract Standardized for Iron + Vitamin c and Botanical Extract Standardized for Iron in Adult Human Subjects With Anemia or Iron-deficiency Anemia N/A
Completed NCT03156712 - Iron Absorption From Iron-enriched Aspergillus Oryzae N/A