Related Experiment Videos

Randomized controlled safety and efficacy trial of 2 vitamin A supplementation schedules in Tanzanian infants

Boniphace Idindili1, Honarati Masanja, Honorathy Urassa

  • 1Ifakara Health Research and Development Centre, Ifakara, Tanzania.

The American Journal of Clinical Nutrition
|May 11, 2007
PubMed

Insights

Doubling vitamin A doses for mothers and infants is safe but doesn't significantly reduce early childhood illness or improve vitamin A status. Further research is needed on vitamin A capsule stability.

Area of Science:

  • Pediatric Nutrition
  • Public Health Interventions
  • Micronutrient Supplementation

Background:

  • Vitamin A deficiency (VAD) poses significant risks to infants, with high morbidity and mortality in early life.
  • Current routine vitamin A supplementation typically begins at 9 months, missing a critical early window.
  • Early-life supplementation could potentially mitigate risks before routine programs commence.

Purpose of the Study:

  • To assess the safety and efficacy of administering vitamin A supplementation to infants aged 1-3 months concurrently with routine vaccinations.
  • To evaluate the impact of increased vitamin A dosage on infant health and vitamin A status.

Main Methods:

  • A randomized double-blind controlled trial involving 780 mother-infant pairs in Tanzania.
  • Two groups: one received standard maternal and infant doses, the other received doubled maternal and infant doses at 1, 2, and 3 months.
  • Vitamin A deficiency (VAD) was defined using a modified relative dose-response test.

Main Results:

  • High-dose vitamin A supplementation was well-tolerated by infants and mothers.
  • No significant difference in the relative risk of VAD at 6 months between high-dose and lower-dose groups (RR 0.91, P=0.32).
  • Serum retinol levels and incidence of illness did not significantly differ between the groups; capsule degradation was noted.

Conclusions:

  • Doubling vitamin A doses for mothers and young infants is safe but unlikely to reduce short-term illness.
  • Enhanced vitamin A dosage did not substantially improve biochemical vitamin A status by 6 months.
  • The stability of vitamin A capsules requires further investigation for reliable supplementation.
Abstract

Related Concept Videos

Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
Drug Dosing: Infants and Children01:29

Drug Dosing: Infants and Children

Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
What is an Experiment?01:12

What is an Experiment?

An experiment is a planned activity carried out under controlled conditions. The purpose of an experiment is to investigate the relationship between two variables. When one variable causes change in another, we call the first variable the explanatory or independent variable. The affected variable is called the response or dependent variable. In a randomized experiment, the researcher manipulates values of the explanatory variable and measures the resulting changes in the response variable. The...
Teratogenicity01:07

Teratogenicity

The ability of a drug to produce structural deformations and functional abnormalities in the developing embryo or the fetus is called teratogenicity, and the drug producing this effect is known as a teratogen. Teratogenic effects include stillbirth, miscarriage, intrauterine growth restriction, and neurocognitive delay. A teratogen may affect the embryo at different stages of development, which is important in determining the type and extent of the damage. During blastocyst formation, the early...
Vaccinations01:51

Vaccinations

Overview