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A study to compare two types of wheat flour - one with high zinc for benefits in zinc status and morbidity among non pregnant women and pre-school children

Efficacy of High Zinc-Biofortified Wheat Consumption in Improvement of Micronutrient Status, and Prevention of Morbidity among Preschool Children (aged 4-6 years) and Women of Child Bearing Age- A Double Masked, Randomized, Controlled Trial - Atta study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/04/004527
Enrollment
6000
Registered
2014-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Community based study for prevention of micronutrient deficiency participants will be healthy non pregnant, non lactating women and children 4-6 years old

Interventions

Intervention1: Wheat Flour with higher zinc content: In this trial both groups are getting wheat flour which is grown in India and certified for marketing by designated system of Govt. of Punjab. The

Sponsors

Harvest Plus
Lead Sponsor
Arti Roller Flour Industries Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Preschool children: Between 4-6 years of age; consenting to participate; likely to live in the study area for at least 6 months, their staple diet is wheat. Women of child-bearing age: Between 15-49 years of age (non-lactating and non pregnant), permanent residents or willing to stay in study area for next six months, their staple diet is wheat.

Exclusion criteria

Exclusion criteria: Preschool children: severely malnourished children requiring rehabilitation. Women of child-bearing age: severe illnesses requiring hospitalization

Design outcomes

Primary

MeasureTime frame
1.Effect on change in proportion of zinc deficient (plasma zinc less than 70.0 µg/dL) subjects. Timepoint: All the outcomes variables will be assessed after the completion of 6 months.

Secondary

MeasureTime frame
1.Effect on diarrheal and non-diarrheal illnesses in children. 2.Effects on physical growth in children. 3.Compliance and acceptability on sustained use of the wheat flour Timepoint: All the secondary outcomes will be assessed during 6 months of intervention and impact assessment calculated after the completion of 6 months.

Countries

India

Contacts

Public ContactDr Ashish Prakash

Center for Public Health Kinetics

ssazawal@jhsph.edu91-11-41724901

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 5, 2026