Multiple Micronutrient Versus Iron-Folic Acid Supplementation in Pregnant Women in Indonesia
Effect of Multiple Micronutrient Supplementation Versus Iron and Folic Acid Supplementation on Maternal Nutritional Biomarkers and Birth Outcomes Among Pregnant Women in Indonesia
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Central Java
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Purwodadi Grobogan, Central Java, Indonesien, 90222
- Puskesmas Grobogan
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Multiple Micronutrient Supplementation
Participants assigned to this arm received one multiple micronutrient supplement daily for eight weeks.
|
One tablet was administered orally once daily for eight weeks.
Andra namn:
|
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Aktiv komparator: Iron and Folic Acid Supplementation
Participants assigned to this arm received one iron and folic acid supplement daily for eight weeks according to the applicable antenatal supplementation standard.
|
One tablet was administered orally once daily for eight weeks.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Maternal Body Weight
Tidsram: 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.
|
Baseline and 8 weeks
|
|
Change in Maternal Mid-Upper Arm Circumference
Tidsram: 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.
|
Baseline and 8 weeks
|
|
Change in Maternal Hemoglobin Concentration
Tidsram: 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: |
Baseline and 8 weeks
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 49/Kom.etik/VI/2025
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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