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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN83465214

Enrollment

770

Registered

2004-09-22

Start date

2001-12-01

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 Vitamin A 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. Prevalence of Vitamin A Deficiency (VAD) (any: less than 20 mg/dL and severe: less than 10 mg/dL) at 6 months of age 2. Incidence of each of the following: 2.1. Bulging fontanelle 2.2. Temperature greater than 37.5°C 2.3. Vomiting 2.4. Diarrhoea 2.5. Inability to suck/feed during the two days following each vitamin A supplementation	—

Secondary

Measure	Time frame
1. Mean serum retinol concentration at 6 months of age 2. Prevalence of VAD (any and severe) at 9 months of age 3. Mean retinol concentration at 9 months of age	—

Countries

Tanzania

Outcome results

None listed

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