Low Birth Weight, Maternal Anemia, Maternal Micronutrient Status, Pregnancy
Conditions
Keywords
Multiple Micronutrient Supplementation, Iron and Folic Acid Supplementation, Maternal Nutrition, Maternal Hemoglobin, Birth Weight, Low Birth Weight
Brief summary
Micronutrient deficiencies during pregnancy may affect the mother's nutritional status and the baby's growth. This study compared two types of daily supplements for pregnant women: a multiple micronutrient supplement and an iron and folic acid supplement. Pregnant women in Indonesia who were at 12 weeks of gestation or earlier were randomly assigned to receive one of the two supplements for eight weeks. The study measured maternal body weight, mid-upper arm circumference, hemoglobin concentration, and serum zinc concentration before and after supplementation. Infant birth weight and the occurrence of low birth weight were assessed after delivery. The purpose of the study was to determine whether multiple micronutrient supplementation produced greater improvements in maternal nutritional indicators and birth outcomes than iron and folic acid supplementation.
Detailed description
This study was designed as a randomized, double-blind, parallel-group trial comparing daily multiple micronutrient supplementation with daily iron and folic acid supplementation among pregnant women in Indonesia. Participants received the assigned supplement for eight weeks. Maternal anthropometric and biochemical indicators were assessed before and after the intervention, and birth outcomes were assessed after delivery. This study was registered retrospectively because prospective registration was inadvertently omitted during study initiation. Information entered in this record was derived from the original study protocol and available study documentation.
Interventions
DIETARY_SUPPLEMENTMultiple micronutrient supplementation
One tablet was administered orally once daily for eight weeks.
DIETARY_SUPPLEMENTIron and Folic Acid Supplementation
One tablet was administered orally once daily for eight weeks.
Sponsors
Indonesia Timur University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Participants were randomly assigned in a 1:1 ratio to one of two parallel intervention groups: multiple micronutrient supplementation or iron and folic acid supplementation. Each participant received the assigned supplement daily for eight weeks and remained in the same intervention group throughout the study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Pregnant women at 12 weeks of gestation or earlier Aged 18 to 40 years No diagnosed chronic disease Willing to complete all study procedures Provided written informed consent
Exclusion criteria
Severe pregnancy complications Known allergy to any supplement ingredient Inability to communicate adequately with the research team Planned relocation from the study area within the following six months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maternal Body Weight | Baseline and 8 weeks | Change in maternal body weight calculated as the value measured after eight weeks of supplementation minus the baseline value, expressed in kilograms. |
| Change in Maternal Mid-Upper Arm Circumference | Baseline and 8 weeks | Change in maternal mid-upper arm circumference calculated as the value measured after eight weeks of supplementation minus the baseline value, expressed in centimeters. |
| Change in Maternal Hemoglobin Concentration | Baseline and 8 weeks | Change in maternal hemoglobin concentration calculated as the value measured after eight weeks of supplementation minus the baseline value, expressed in g/dL. Time Frame: |
Countries
Indonesia
Outcome results
None listed