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 childre
Not Applicable
Completed
- 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
- Registration Number
- CTRI/2014/04/004527
- Lead Sponsor
- Harvest Plus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6000
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
Preschool children: severely malnourished children requiring rehabilitation.
Women of child-bearing age: severe illnesses requiring hospitalization
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Effect on change in proportion of zinc deficient (plasma zinc less than 70.0 µg/dL) subjects. <br/ ><br>Timepoint: All the outcomes variables will be assessed after the completion of 6 months.
- Secondary Outcome Measures
Name Time Method 1.Effect on diarrheal and non-diarrheal illnesses in children. <br/ ><br>2.Effects on physical growth in children. <br/ ><br>3.Compliance and acceptability on sustained use of the wheat flour <br/ ><br>Timepoint: All the secondary outcomes will be assessed during 6 months of intervention and impact assessment calculated after the completion of 6 months.