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CompletedNCT01751009vitapoolUpdated Dec 17, 2012

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

An interventional study of Vitamin A supplements and Sprinkles without Vitamin A in Malnutrition, sponsored by Kintampo Health Research Centre, Ghana. Completed at 1 site in Ghana. Open to participants aged 6 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-17.

Sponsored by Kintampo Health Research Centre, Ghana · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
6 Months to 12 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Malnutrition

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Keywords

  • vitamin A, complementary foods, malnutrition, children
03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 93 is close to the median of 90 across 1,134 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Kintampo Health Research Centre, Ghana is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 12 Months
Sexes eligible
All
Accepts 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

Exclusion Criteria:

Child's haemoglobin level less than 70 g/L.

Unable to give informed consent

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
93 participants (actual)

Study arms

  • Experimental
    Vitamin A supplements

    Sprinkles with Vitamin A

    Dietary Supplement: Vitamin A supplements

  • Active comparator
    Sprinkles without Vitamin A

    Made of other micronutrients without Vitamin A

    Dietary Supplement: Sprinkles without Vitamin A

Interventions

  • Dietary supplementVitamin A supplements

    Sprinkles with Vitamin A

  • Dietary supplementSprinkles without Vitamin A

    Active comparator

06

What researchers measure

Primary outcomes

  1. Vitamin A status after 5 months supplementation

    Time frame: 5 months

Secondary outcomes

  1. acceptability of home based fortified vitamin A supplements

    Time frame: 5 months

07

Study locations

1 site
  • Kintampo North Municipality
    Kintampo, Ghana
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01751009
Lead sponsor
Kintampo Health Research Centre, Ghana
Collaborators
University of Wisconsin, Madison
Responsible party
Sponsor
First posted
Dec 17, 2012
Start date
Jan 2010
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Dec 17, 2012

Study contacts

Sherry Tanumihardjo, PhD
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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