Prevention of vitamin A deficiency by supplementation alongside routine vaccinations: a randomised controlled trial in Ghana infants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN97670178

Enrollment

1400

Registered

2004-11-24

Start date

2004-01-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Vitamin A Deficiency Nutritional, Metabolic, Endocrine Nutritional deficiency

Interventions

1st Group: 1. Mothers 200,000 IU Vitamin A shortly after delivery 2. Infants: 25,000 IU Vitamin A with each Diphtheria, Pertussis, Tetanus (DPT) vaccine 1, 2 and 3 2nd Group: 1. Mothers 200,000 IU

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Mothers normally resident in the study area 2. Informed consent obtained from the mother

Exclusion criteria

Exclusion criteria: 1. Mothers unable to give informed consent 2. Mothers considered to be at high risk of adverse outcome in puerperal period 3. Multiple deliveries 4. Severe adverse reaction to vitamin A supplementation

Design outcomes

Primary

Measure	Time frame
1. Serum retinol levels, assessed by carrying out mRDR testing of infants at 6 weeks, 6 months and 9 months 2. Modified Retinol Dose Response (mRDR) tests 3. Incidence of side effects such as bulging of the anterior fontanel and vomiting 4. Incidence of severe morbidity	—

Secondary

Measure	Time frame
1. Breast milk retinol concentrations, assessed at 6 weeks, 6 months and 9 months for an assessment of the impact of the different supplementation regimes 2. mRDR testing of infants at 9 months of age	—

Countries

Ghana

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026