NCT02152150

Brief Summary

The objective of this study was to evaluate the efficacy of iron bio-fortified pearl millet in improving iron status in adolescents in India.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

September 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

Enrollment Period

6 months

First QC Date

May 13, 2014

Last Update Submit

May 28, 2014

Conditions

Iron Deficiency and Anemia

Keywords

ironanemiabio-fortificationchildrenIndia

Outcome Measures

Primary Outcomes (1)

  • Change in iron status

    Hemoglobin, serum ferritin, serum transferrin receptor, body iron

    6 months

Secondary Outcomes (2)

  • Differences in cognitive function

    6 months

  • Differences in physical performance

    6 months

Study Arms (2)

Iron bio-fortified pearl millet

EXPERIMENTAL

Pearl millet variety ICTP8203-Fe (82 mg/kg iron content)

Other: Iron bio-fortified pearl millet

Control pearl millet

ACTIVE COMPARATOR

Conventional pearl millet: variety DG9444 (22 mg/kg iron content) and JKBH778 (52 mg/kg iron content)

Other: Control pearl millet

Interventions

Iron bio-fortified pearl milletOTHER

Pearl millet variety ICTP8203-Fe (82 mg/kg iron content) prepared as a traditional flatbread (bhakri)

Iron bio-fortified pearl millet
Control pearl milletOTHER

Conventional pearl millet: variety DG9444 (22 mg/kg iron content) and JKBH778 (52 mg/kg iron content), prepared as a traditional flatbread (bhakri)

Control pearl millet

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participants are individuals aged 12 to 16 years
  • Attending boarding schools in Ahmednagar district, Maharashtra, India

You may not qualify if:

  • Severe anemia (Hemoglobin\<8.5g/dL)
  • Taking iron supplements or medications that could interfere with iron absorption
  • Chronic illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.N.D.T. Women's University

Mumbai, India

Location

Related Publications (3)

  • Wenger MJ, Murray Kolb LE, Scott SP, Boy E, Haas JD. Modeling relationships between iron status, behavior, and brain electrophysiology: evidence from a randomized study involving a biofortified grain in Indian adolescents. BMC Public Health. 2022 Jul 6;22(1):1299. doi: 10.1186/s12889-022-13612-z.

    PMID: 35794587DERIVED

  • Scott SP, Murray-Kolb LE, Wenger MJ, Udipi SA, Ghugre PS, Boy E, Haas JD. Cognitive Performance in Indian School-Going Adolescents Is Positively Affected by Consumption of Iron-Biofortified Pearl Millet: A 6-Month Randomized Controlled Efficacy Trial. J Nutr. 2018 Sep 1;148(9):1462-1471. doi: 10.1093/jn/nxy113.

    PMID: 30016516DERIVED

  • Finkelstein JL, Mehta S, Udipi SA, Ghugre PS, Luna SV, Wenger MJ, Murray-Kolb LE, Przybyszewski EM, Haas JD. A Randomized Trial of Iron-Biofortified Pearl Millet in School Children in India. J Nutr. 2015 Jul;145(7):1576-81. doi: 10.3945/jn.114.208009. Epub 2015 May 6.

    PMID: 25948782DERIVED

MeSH Terms

Conditions

Anemia, Iron-DeficiencyAnemia

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jere D. Haas, Ph.D.

    Cornell University

    PRINCIPAL INVESTIGATOR

  • Shobha Udipi, Ph.D.

    SNDT Women's University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 13, 2014

First Posted

June 2, 2014

Study Start

September 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

June 2, 2014

Record last verified: 2014-05

Locations

IN(1)