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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02422953
Date of registration:	15/04/2015
Prospective Registration:	No
Primary sponsor:	Aga Khan University
Public title:	Stunting Prevention Project in Thatta and Sujawal Districts, Sindh Province, Pakistan
Scientific title:	Effectiveness of Food/Nutrient Based Interventions to Prevent Stunting Among Children Under Five in Thatta and Sujawal Districts, Sindh Province, Pakistan
Date of first enrolment:	August 2014
Target sample size:	4020
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02422953
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Pakistan

Contacts

Name:	Sajid B Soofi, FCPS
Address:
Telephone:
Email:
Affiliation:	Aga Khan University

Key inclusion & exclusion criteria

Inclusion Criteria:

- All pregnant women

- All lactating mothers (upto 6 months)

- All children 6-23 months of age

- All children 24-59 months of age

Exclusion Criteria:

- Refuse to participate in the study

- Having severe chronic disease

Age minimum: 6 Months
Age maximum: 59 Months
Gender: All

Health Condition(s) or Problem(s) studied

Malnutrition

Intervention(s)

Dietary Supplement: Micronutrient Powders (MNP)

Behavioral: Behavior change and preventive health massages

Dietary Supplement: Wawa Mum

Dietary Supplement: Wheat Soya Blend (WSB)

Primary Outcome(s)

Stunting-reduction in stunted children in intervention group [Time Frame: 2 Years]

Secondary Outcome(s)

Mean hemoglobin concentration in mothers [Time Frame: 2 Years]

Mean change in weight-for-age z-score (WAZ) [Time Frame: 2 Years]

Pregnancy out come [Time Frame: 2 Years]

Impact on vitamin A status in children at 24 months [Time Frame: 2 Years]

Mean change in weight-for-height z-score (WHZ) [Time Frame: 2 Years]

Prevalence of maternal anemia (Hb concentration<12g/dL) [Time Frame: 2 Years]

Impact on maternal BMI [Time Frame: 2 Years]

Impact on Zinc status in children at 24 months [Time Frame: 2 Years]

Mean hemoglobin concentration in children 6-59 months of age [Time Frame: 2 Years]

Improvement in infant and young child feeding (IYCF) indicators [Time Frame: 2 Years]

Linear growth velocity (HAZ increment/month) [Time Frame: 2 Years]

Impact on Ferritin status in children at 24 months [Time Frame: 2 Years]

Impact on vitamin D status in children at 24 months [Time Frame: 2 Years]

Prevalence of childhood anemia (Hb concentration<11g/dL) in children 6-59 months of age [Time Frame: 2 Years]

Secondary ID(s)

WFP-Thatta

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

United Nations World Food Programme (WFP)

Pakistan Ministry of Health

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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