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

NCT02421653 | Withdrawn DMC

• 1 other identifier: EK-2014-N-35
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Micronutrient powders; MNP; Weaning; Home fortification; Iodine; Iodine deficiency; Iodine Deficiency Disorder; IDD; Infant; Growth; Iodised oil

Outcome Measures

Primary Outcomes (2)

• Infant urinary iodine concentration (UIC)

  24 weeks

• Infant dried blood spot thyroglobulin (DBS-Tg)

  24 weeks

Secondary Outcomes (5)

• Infant dried blood spot TSH (DBS-TSH)

  24 weeks

• Infant dried blood spot total T4 (DBS-T4)

  24 weeks

• Infant somatic growth (head circumference, weight, length)

  24 weeks, and if results significant at this point, 52 weeks

• Thyroid autoimmunity

  24 weeks

• Safety (Composite measure of infant morbidities and infant mortality)

  24 weeks

Other Outcomes (4)

• Infant urinary creatinine concentration

  24 weeks

• Infant urinary sodium concentration

  24 weeks

• Mother urinary iodine concentration (UIC)

  24 weeks

Study Arms (4)

MNP90 + INERT OIL

EXPERIMENTAL

Daily micronutrient powders (14 micronutrients) containing 90 µg iodine as potassium iodate plus one inert oil capsule without iodine at the study start;

Dietary Supplement: MNP90; Dietary Supplement: INERT OIL

MNP45 + INERT OIL

EXPERIMENTAL

Daily micronutrient powders (14 micronutrients) containing 45 µg iodine as potassium iodate plus one inert oil capsule without iodine at the study start;

Dietary Supplement: MNP45; Dietary Supplement: INERT OIL

IODISED OIL + INERT MNP

EXPERIMENTAL

Daily inert powder (maltodextrin, no micronutrients) plus one oral dose of 200 mg iodine as iodised poppy seed oil at the study start

Dietary Supplement: IODISED OIL; Dietary Supplement: INERT MNP

NON-IODISED MNP + INERT OIL

ACTIVE COMPARATOR

Daily micronutrient powders (14 micronutrients) without iodine plus one inert oil capsule without iodine at the study start.

Dietary Supplement: INERT OIL; Dietary Supplement: NON-IODISED MNP

Interventions

MNP90 DIETARY_SUPPLEMENT

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

MNP90 + INERT OIL

MNP45 DIETARY_SUPPLEMENT

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

MNP45 + INERT OIL

IODISED OIL DIETARY_SUPPLEMENT

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

IODISED OIL + INERT MNP

INERT OIL DIETARY_SUPPLEMENT

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

MNP45 + INERT OIL; MNP90 + INERT OIL; NON-IODISED MNP + INERT OIL

INERT MNP DIETARY_SUPPLEMENT

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

IODISED OIL + INERT MNP

NON-IODISED MNP DIETARY_SUPPLEMENT

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

NON-IODISED MNP + INERT OIL

Eligibility Criteria

• Age: 6 Months - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Ages:
• For pilot - aged 6 - 18 months (+2 weeks, no infant \< 6 months)
• For intervention - aged 6 - 9 months (+2 weeks, no infant \< 6 months)
• Born to a healthy singleton pregnancy
• Term (week 38 to 42) delivery
• Family residence at the study site for at least 12 months prior to the start of the study and anticipated residence for at least a further 12 months (mother and infant)
• Exclusively breastfed for at least 2 months, or if not, having received no other sources of iodine intake (in formula, supplements, or foods)
• Signed informed consent
• Suffering from severe acute malnutrition(\< 3 weight-for-height z-scores)
• Known history of medical illnesses
• Taking chronic medications (mother and infant)
• Use of iodine containing dietary supplements during the last 6 months (mother and infant)
• Exposure to iodine containing X-ray / CT contrast agent, skin disinfectants or medications during the last 6 months (mother and infant)
• Participation in any other clinical study (mother and infant) or participated in the pilot study (infant)
• NB: Severe Acute Malnutrition is defined as being below 3 standard deviations (SD) of the WHO standard for weight-for-height ratio for infants and children aged 6 to 60 months. All infants identified with SAM will be excluded from the study and referred to hospital or nutrition clinic for treatment.

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• UNICEF: collaborator
• Global Alliance for Improved Nutrition: collaborator

MeSH Terms

Interventions

Iodized Oil

Intervention Hierarchy (Ancestors)

Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Michael B Zimmermann, MD

  ETH Zuerich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: April 21, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 30, 2017

Record last verified: 2017-01