NCT01783067

Brief Summary

Populations who consume non-fortified plant-based diets are at increased risk of iron and zinc deficiencies. The purpose of this randomized controlled study is to determine the absorption of iron and zinc from pearl millet biofortified with these two micronutrients. Forty children aged 2 years in Kanartaka, India are randomized to consume biofortified pearl millet (Group 1) or control pearl millet (Group 2) for two days. Quantities of zinc and iron absorbed are measured with established stable isotope extrinsic labeling techniques and analyses of duplicate diets.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
2 countries

2 active sites

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

Study Start

First participant enrolled

February 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

January 28, 2013

Last Update Submit

April 26, 2016

Conditions

Nutritional Deficiency

Keywords

BiofortificationPearl milletIron absorptionZinc absorption

Outcome Measures

Primary Outcomes (2)

  • Absorption of iron from pearl millet

    Absorption of iron will be measured while the participants are eating pearl millet as their major food staple which will provide at least 50% energy and at least 75% iron, zinc and phytate of the diet. Fractional absorption of iron for two days will be measured by extrinsic labeling with stable isotopes of iron and measuring erythrocyte enrichment. Measurement of total iron in duplicate diets on test days will allow determination of quantity of this micronutrient absorbed (mg/d).

    2 days

  • Absorption of zinc from pearl millet

    Absorption of zinc will be measured while the participants are eating pearl millet as their major food staple which will provide at least 50% energy and at least 75% iron, zinc and phytate of the diet. Fractional absorption of zinc for a day will be measured by extrinsic labeling with stable isotopes of zinc. Fractional absorption of zinc will be measured by a dual isotope tracer ratio technique. Measurement of total zinc in duplicate diets on test day will allow determination of quantity of this micronutrient absorbed (mg/d).

    1 day

Study Arms (2)

Iron and zinc biofortified pearl millet

EXPERIMENTAL

Participants in the experimental arm consume pearl millet which has been biofortified with iron and zinc.

Other: Biofortified pearl millet

Pearl millet

ACTIVE COMPARATOR

Participants in the control arm consume non-biofortified pearl millet.

Other: Pearl millet

Interventions

Pearl milletOTHER

Participants in the control arm consume pearl millet which has not been biofortified. The intervention is consumed for two days.

Pearl millet
Biofortified pearl milletOTHER

Participants in the experimental arm consume pearl millet biofortified with iron and zinc. The intervention is consumed for two days.

Iron and zinc biofortified pearl millet

Eligibility Criteria

Age18 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • lives in one of the targeted communities
  • apparently healthy
  • m of age \[may need modification\]
  • Hemoglobin (Hb) \> 8 g/dl
  • ferritin ≤ 12mg/L

You may not qualify if:

  • Hemoglobin (Hb) \< 8g/dl
  • serum ferritin \> 12 (even after correction for C-reactive protein (CRP)/ Alpha Glyco Protein (AGP)
  • thalassemia
  • birth weight \< 2,500 g
  • birth defect affecting growth and development
  • chronic infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

JN Medical College (Human field studies)

Belagavi, Karnataka, India

Location

Related Publications (2)

  • Kodkany BS, Bellad RM, Mahantshetti NS, Westcott JE, Krebs NF, Kemp JF, Hambidge KM. Biofortification of pearl millet with iron and zinc in a randomized controlled trial increases absorption of these minerals above physiologic requirements in young children. J Nutr. 2013 Sep;143(9):1489-93. doi: 10.3945/jn.113.176677. Epub 2013 Jul 10.

    PMID: 23843474BACKGROUND

  • Miller LV, Hambidge KM, Krebs NF. Zinc Absorption Is Not Related to Dietary Phytate Intake in Infants and Young Children Based on Modeling Combined Data from Multiple Studies. J Nutr. 2015 Aug;145(8):1763-9. doi: 10.3945/jn.115.213074. Epub 2015 Jun 24.

    PMID: 26108545BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Michael Hambidge, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

February 4, 2013

Study Start

February 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 28, 2016

Record last verified: 2016-04

Locations

US(1)IN(1)