Diarrheal Illnesses, Respiratory Illness, Growth Faltering
Conditions
Keywords
HIV, Tanzania, Micronutrients, Infants/children, Infectious Disease, Growth faltering
Brief summary
A randomized clinical trial of multiple micronutrients, zinc, zinc + micronutrients, or placebo among 2400 children born to HIV-negative Tanzanian mothers.
Detailed description
We propose to study the efficacy of zinc or multiple micronutrient supplementation in reducing the risk of infectious diseases and growth faltering among infants and young children in Tanzania. Infants born to HIV-negative women will be recruited and randomly assigned in a factorial design to either zinc, micronutrients (vitamins C, E, B1, B2, niacin, B6, folate and B12), micronutrients plus zinc, or a placebo given daily. Children will be followed at monthly clinic visits from age 6 weeks for 18 months. Data obtained will include socioeconomic status, anthropometric data (weight, length, head circumference, and arm anthropometrics), dietary intake (including breastfeeding duration and frequency), hemoglobin, ferritin, and blood smear for malaria. The primary outcomes will be the incidence of diarrhea and respiratory tract infections. Secondary outcomes will be weight and length gain. A subset of children will be tested for blood concentrations of vitamin A, E, zinc and C-reactive protein. All children will receive a large periodic dose of vitamin A every 6 months as per standard of care in Tanzania.
Interventions
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Harvard School of Public Health (HSPH)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Singleton, live born infants born to HIV- negative women * Mothers will need to have registered for pre-natal care before 34 weeks gestation * intend to stay in Dar es Salaam for until delivery and 18 months thereafter.
Exclusion criteria
* infants born with multiple congenital abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of diarrhea | from ages 6 weeks to 18 months |
| respiratory tract infections | from ages 6 weeks to 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Weight gain | from age 6 weeks to 18 months |
| Length/height gain | from age 6 weeks to 18 months |
Countries
Tanzania
Outcome results
None listed