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RCT of Iodine-containing MNPs vs Oral Iodized Oil to Prevent Iodine Deficiency in Weaning Infants

NCT02421653 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-01-30

No results posted yet for this study

Summary

In this study, two intervention strategies to address iodine deficiency and prevent iodine deficiency disorders in breast-fed weaning infants will be evaluated in a mild to moderate iodine-deficient population in Zamboanga del Norte, Philippines, Southeast Asia.

Conditions

  • Iodine Deficiency Disorders

Interventions

DIETARY_SUPPLEMENT

MNP90

90 µg iodine-fortified micronutrient powder sachet (14 micronutrients); oral route; 1 daily

DIETARY_SUPPLEMENT

MNP45

45 µg iodine-fortified micronutrient powder sachet (14 micronutrients); oral route; 1 daily

DIETARY_SUPPLEMENT

IODISED OIL

200 mg iodine oil capsule; oral route; once at study start

DIETARY_SUPPLEMENT

INERT OIL

Non-iodised evening primrose oil capsule; oral route; once at study start

DIETARY_SUPPLEMENT

INERT MNP

Un-fortified powder sachet (maltodextrin, no micronutrients); oral route; 1 daily

DIETARY_SUPPLEMENT

NON-IODISED MNP

Un-fortified micronutrient powder sachet (14 micronutrients); oral route; 1 daily

Sponsors & Collaborators

  • UNICEF

    collaborator OTHER

  • Global Alliance for Improved Nutrition

    collaborator OTHER

  • Swiss Federal Institute of Technology

    lead OTHER

Principal Investigators

  • Michael B Zimmermann, MD · ETH Zuerich

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
9 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-12-31
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02421653 on ClinicalTrials.gov