NCT00613717

Brief Summary

The Healthy Infant Development Project will determine if providing micronutrient supplements to mothers during pregnancy and infants in the first 9 months fosters healthy behavior and development in babies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,371

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 29, 2014

Status Verified

March 1, 2014

Enrollment Period

4.6 years

First QC Date

February 11, 2008

Last Update Submit

October 28, 2014

Conditions

Iron Deficiency AnemiaIron Deficiency

Keywords

iron deficiency anemiairon deficiencyinfantdevelopmentbehavior

Outcome Measures

Primary Outcomes (1)

  • Infant behavior and development

    9 and 18 months

Secondary Outcomes (1)

  • Infant anemia

    9 and 18 months

Study Arms (4)

a

EXPERIMENTAL

pre- and early postnatal iron

Dietary Supplement: folic acid + iron prenatally, vits A & D + iron postnatally

b

EXPERIMENTAL

iron prenatal only

Dietary Supplement: folic acid + iron prenatally, vitamins A & D postnatally

c

EXPERIMENTAL

iron early postnatal only

Dietary Supplement: folic acid prenatally, vitamins A & D + iron postnatally

d

ACTIVE COMPARATOR

no iron pre- or postnatal

Dietary Supplement: folic acid prenatally, vitamins A & D postnatally

Interventions

folic acid + iron prenatally, vits A & D + iron postnatallyDIETARY_SUPPLEMENT

Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe. Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1 mg/kg/day Fe, 1500 IU vitamin A, 500 IU vitamin D.

a
folic acid + iron prenatally, vitamins A & D postnatallyDIETARY_SUPPLEMENT

Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe. Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1500 IU vitamin A, 500 IU vitamin D.

b
folic acid prenatally, vitamins A & D + iron postnatallyDIETARY_SUPPLEMENT

Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid. Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1 mg/kg/day Fe, 1500 IU vitamin A, 500 IU vitamin D.

c
folic acid prenatally, vitamins A & D postnatallyDIETARY_SUPPLEMENT

Prenatally: pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid. Postnatally: liquid by mouth, once per day, from 6 weeks old until 9 months old, 1500 IU vitamin A, 500 IU vitamin D.

d

Eligibility Criteria

Age1 Day - 5 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- Full-term healthy neonates born to study mothers from CDC's Prenatal Nutrition Study with randomly selected lot numbers.

You may not qualify if:

  • birth weight \< 2500 g
  • gestational age ≤ 37 wk
  • major perinatal complications
  • major congenital anomaly
  • multiple birth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, 100034, China

Location

Related Publications (2)

  • Clark KM, Li M, Zhu B, Liang F, Shao J, Zhang Y, Ji C, Zhao Z, Kaciroti N, Lozoff B. Breastfeeding, Mixed, or Formula Feeding at 9 Months of Age and the Prevalence of Iron Deficiency and Iron Deficiency Anemia in Two Cohorts of Infants in China. J Pediatr. 2017 Feb;181:56-61. doi: 10.1016/j.jpeds.2016.10.041. Epub 2016 Nov 8.

    PMID: 27836288DERIVED

  • Lozoff B, Jiang Y, Li X, Zhou M, Richards B, Xu G, Clark KM, Liang F, Kaciroti N, Zhao G, Santos DC, Zhang Z, Tardif T, Li M. Low-Dose Iron Supplementation in Infancy Modestly Increases Infant Iron Status at 9 Mo without Decreasing Growth or Increasing Illness in a Randomized Clinical Trial in Rural China. J Nutr. 2016 Mar;146(3):612-21. doi: 10.3945/jn.115.223917. Epub 2016 Jan 20.

    PMID: 26791556DERIVED

MeSH Terms

Conditions

Anemia, Iron-DeficiencyIron DeficienciesBehavior

Interventions

Folic AcidFumigant 93

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Betsy Lozoff, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Li Ming, MD

    Peking University First Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2008

First Posted

February 13, 2008

Study Start

November 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 29, 2014

Record last verified: 2014-03

Locations

CN(1)