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.
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Central Java
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Purwodadi Grobogan, Central Java, Indonésie, 90222
- Puskesmas Grobogan
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Multiple Micronutrient Supplementation
Participants assigned to this arm received one multiple micronutrient supplement daily for eight weeks.
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One tablet was administered orally once daily for eight weeks.
Autres noms:
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Comparateur actif: 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.
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One tablet was administered orally once daily for eight weeks.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Maternal Body Weight
Délai: Baseline and 8 weeks
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Change in maternal body weight calculated as the value measured after eight weeks of supplementation minus the baseline value, expressed in kilograms.
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Baseline and 8 weeks
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Change in Maternal Mid-Upper Arm Circumference
Délai: Baseline and 8 weeks
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Change in maternal mid-upper arm circumference calculated as the value measured after eight weeks of supplementation minus the baseline value, expressed in centimeters.
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Baseline and 8 weeks
|
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Change in Maternal Hemoglobin Concentration
Délai: Baseline and 8 weeks
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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
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 49/Kom.etik/VI/2025
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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