NCT03514472

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

April 19, 2018

Last Update Submit

May 1, 2018

Conditions

Anemia, Iron Deficiency

Keywords

Hb, Anemia,

Outcome Measures

Primary Outcomes (1)

  • Improvement in Hemoglobin status

    Comparison of Hb levels pre and post intervention

    3 months

Secondary Outcomes (1)

  • Changes in BMI

    5 months

Study Arms (2)

Group A (Below 18 years)

ACTIVE COMPARATOR

Dried Moringa oleifera leaves (15g/recipe)

Dietary Supplement: Dried Moringa oleifera leaves

Group B (Above 18)

ACTIVE COMPARATOR

Dried Moringa oleifera leaves (15g/recipe)

Dietary Supplement: Dried Moringa oleifera leaves

Interventions

Dried Moringa oleifera leavesDIETARY_SUPPLEMENT
Group A (Below 18 years)Group B (Above 18)

Eligibility Criteria

Age13 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsReproductive aged females ( those who are capable of bearing a child)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Reproductive aged females (13-30 years)

You may not qualify if:

  • pregnant and Lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Anwar F, Bhanger MI. Analytical characterization of Moringa oleifera seed oil grown in temperate regions of Pakistan. J Agric Food Chem. 2003 Oct 22;51(22):6558-63. doi: 10.1021/jf0209894.

    PMID: 14558778BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-DeficiencyAnemia

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Madeeha Munir, M.Phil

    Kinnaird College for Women

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Former Lecturer Minhaj University

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 2, 2018

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

April 1, 2014

Last Updated

May 2, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share