Efficacy of Zn Biofortified Wheat in Improving Zn Status in Indian School Children With Low Zn Status

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Zinc Deficiency

Treatments: Dietary Supplement: Fortification; Dietary Supplement: Control; Dietary Supplement: Biofortified wheat

Study type: Interventional

Funder types: Other

Identifiers

NCT02241330

EK 2013-N-52

Details and patient eligibility

About

The objective of this research is to test the efficacy of Zn biofortified wheat in increasing Zn status in Indian school children aged 6-12 y via a 6 month randomized controlled trial.

Enrollment: 284 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• generally healthy

Exclusion criteria

• unhealthy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

284 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Control wheat used for meal, level of zinc is usual

Treatment:

Dietary Supplement: Control

fortification

Active Comparator group

Description:

Fortification Wheat is fortified before testmeal administration. Zinc level is comparable to WHO recommendation

Treatment:

Dietary Supplement: Fortification

Biofortified

Active Comparator group

Description:

Biofortification Biofortified wheat is used for testmeal administration. Zinc concentration is around 30% higher than control

Treatment:

Dietary Supplement: Biofortified wheat