NCT00379158

Brief Summary

  1. 1.At 12 mo of age, all three intervention groups will have significantly better iron and vitamin A status than the NI group.
  2. 2.Infants who receive the Foodlet or Nutributter will have significantly greater weight and length gains from 6 to 12 mo and higher indices of vitamin B6, riboflavin and zinc status at 12 mo of age than the infants who receive the sprinkles containing iron and vitamin A only.
  3. 3.Infants who receive Nutributter will have significantly greater weight and length gains from 6 to 12 mo and higher indices of vitamin A and essential fatty acid (linoleic, alpha-linolenic and docosahexaenoic, DHA) status at 12 mo of age than the infants who receive the Foodlet or sprinkles.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
393

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

First QC Date

September 20, 2006

Last Update Submit

May 24, 2017

Conditions

Micronutrients

Keywords

multiple micronutrient supplementshome-fortificationcomplementary foodsinfantsGhana

Outcome Measures

Primary Outcomes (3)

  • Growth (weight, length, head circumference)

  • Hemoglobin

  • Micronutrient status (Iron, retinol, B2, B6, zinc, plasma fatty acids)

Secondary Outcomes (3)

  • Motor milestone acquisition

  • Morbidity

  • Energy intake from complementary foods

Interventions

Micronutrient supplementsDRUG

Eligibility Criteria

Age5 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • approximately 5 mo of age
  • receiving breast milk
  • free of congenital abnormality
  • expected to stay in the town for at least the subsequent six months.

You may not qualify if:

  • medically diagnosed chronic illness (including asthma or eczema)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Kathryn G Dewey, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Anna Lartey, PhD

    University of Ghana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2006

First Posted

September 21, 2006

Study Start

October 1, 2003

Study Completion

April 1, 2005

Last Updated

May 30, 2017

Record last verified: 2017-05