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

Kintampo Health Research Centre, Ghana

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: Sprinkles without Vitamin A; Dietary Supplement: Vitamin A supplements

Study type: Interventional

Funder types: Other

Identifiers

NCT01751009

IORG0004854

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 6 to 12 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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93 participants in 2 patient groups

Vitamin A supplements

Experimental group

Description:

Sprinkles with Vitamin A

Treatment:

Dietary Supplement: Vitamin A supplements

Sprinkles without Vitamin A

Active Comparator group

Description:

Made of other micronutrients without Vitamin A

Treatment:

Dietary Supplement: Sprinkles without Vitamin A