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Effects of Fortified Complementary Foods on Vitamin A Status and Body Pool Size in Ghanaian Infants.

A Randomised Controlled Home-based Trial of the Effects of Fortified Complementary Foods on Vitamin A Status and Body Pool Size in Ghanaian Infants.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01751009
Acronym
vitapool
Enrollment
93
Registered
2012-12-17
Start date
2010-01-31
Completion date
2010-06-30
Last updated
2012-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

vitamin A, complementary foods, malnutrition, children

Brief summary

This study tried to prove that children given food supplements containing vitamin A would have better liver vitamin A stores than children given food supplements without vitamin A over a 5 month period.

Detailed description

The study wanted to assess the effect of fortification of home based complementary foods on vitamin A status in Ghanaian children who receive food supplements known as Sprinkles. The study assessed the vitamin A status and body pool size in children using a test known as the modified relative dose response test (MRDR) tests and stable 13C2 retinol as a tracer, among those who receive Sprinkles with or without vitamin A through home fortification of complementary foods.

Interventions

DIETARY_SUPPLEMENTVitamin A supplements

Sprinkles with Vitamin A

DIETARY_SUPPLEMENTSprinkles without Vitamin A

Active comparator

Sponsors

University of Wisconsin, Madison
CollaboratorOTHER
Kintampo Health Research Centre, Ghana
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 12 Months
Healthy volunteers
Yes

Inclusion criteria

Informed consent of mother of eligible children aged 6-12 months. Willingness to remain in the study area for entire duration of the study. Willingness to agree to feed the child with supplied micronutrient supplements for duration of study. The child should have started taking complementary foods in addition to breast milk. Child's haemoglobin level of at least 70 g/L.

Exclusion criteria

Child's haemoglobin level less than 70 g/L. Unable to give informed consent

Design outcomes

Primary

MeasureTime frame
Vitamin A status after 5 months supplementation5 months

Secondary

MeasureTime frame
acceptability of home based fortified vitamin A supplements5 months

Countries

Ghana

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026