NCT03647553

Brief Summary

The proposed study will be a cross-sectional study in the District of Matiari, Pakistan. Children ages 9-15 years will be identified from a Matiari District household census scheduled being conducted from December 2016- to May 2017 by the Department of Pediatrics and Child Health, Aga Khan University. Anthropometric measures, Tanner Stage, Hemoglobin concentration, blood draw as well as questionnaires will be assessed in all participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,385

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 23, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

August 23, 2018

Last Update Submit

July 26, 2021

Conditions

Adolescent DevelopmentStuntingDepressionMicronutrient Deficiency

Outcome Measures

Primary Outcomes (1)

  • Stunting

    \< -2 Height-for-age z-score

    through study completion, an average of 1 year

Secondary Outcomes (7)

  • Factors associated with impaired linear growth

    through study completion, an average of 1 year

  • Anemia and micronutrient deficiencies

    through study completion, an average of 1 year

  • Household Dietary Diversity Scale (HDDS)

    through study completion, an average of 1 year

  • Food Insecurity Experience Scale (FIES)

    through study completion, an average of 1 year

  • Anxiety

    through study completion, an average of 1 year

  • +2 more secondary outcomes

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The study will be conducted in Matiari District in the Province of Sindh, Pakistan. The population of Matiari (2017) was estimated to be 769,349 with approximately 85% being rural. There are approximately 48,000 school-aged children between 9.0 and 15.9 years of age living in the District, which is representative of rural conditions in Pakistan.

You may qualify if:

  • All girls between 9.0-14.9 years of age and boys between 10.0-15.9 years of age at the time of enrollment who are permanent residents of Matiari are eligible to participate in the Nash-wo-Numa Study.
  • The participant's birth mother must also be available to participate in the study and be cognitively able to answer questions since they will be able to provide more accurate information about the birth characteristics of the participant as well as household information like dietary intake

You may not qualify if:

  • Children not meeting the age criteria will not be invited to participate in the study. Female participants who are pregnant or have been pregnant will be excluded from the study.
  • Participants must not be participating in any other nutrition trials. Participants with known chronic or genetic diseases that impact growth will be excluded.
  • An illustrative list of conditions include: congenital heart disease, metabolic disorders (e.g. diabetes), cancer, genetic disorders (Down's syndrome, Turner's syndrome), blood disorders (symptomatic thalassemia, sickle cell anaemia), chronic disorders (kidney i.e. nephrotic syndrome, gastrointestinal i.e. Crohn's, bone dysplasia, immunodeficiency disorders).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Matiari Research and Training Centre

Matiari, Sindh, Pakistan

Location

Related Publications (2)

  • Campisi SC, Humayun KN, Wasan Y, Soofi SB, Islam M, Hussain A, Shakeel A, Vandermorris A, Soder O, Bhutta ZA. The relationship between pubertal timing and under-nutrition in rural Pakistan. J Adolesc. 2021 Apr;88:58-66. doi: 10.1016/j.adolescence.2021.02.002. Epub 2021 Feb 19.

    PMID: 33618265DERIVED

  • Campisi SC, Wasan Y, Soofi S, Monga S, Korczak DJ, Lou W, Soder O, Vandermorris A, Humayun KN, Mian A, Szatmari P, Bhutta ZA. Nash-wo-Numa (childhood growth & development) study protocol: factors that impact linear growth in children 9 to 15 years of age in Matiari, Pakistan. BMJ Open. 2019 Jun 12;9(6):e028343. doi: 10.1136/bmjopen-2018-028343.

    PMID: 31196903DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

As described in the protocol. Blood specimen will be stored for future analysis of few assays, based on funding.

MeSH Terms

Conditions

Growth DisordersDepression

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Founding Director of the Center of Excellence in Women and Child Health

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 27, 2018

Study Start

October 1, 2018

Primary Completion

February 28, 2020

Study Completion

March 31, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

PA(1)