NCT02756026

Brief Summary

The purpose of the study is to establish a protocol for collecting representative samples of breastmilk (BM) that can be used to assess the effect of maternal micronutrient (MN) supplementation on milk MN concentrations. The investigators will determine which breastfeeding episode during the 24 hour period best represents the maternal status; and within the episode whether fore, mid or hind milk samples be collected in future studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

5 months

First QC Date

April 13, 2016

Last Update Submit

April 26, 2016

Conditions

Micronutrient Deficiency

Keywords

Breast milkmineralvitamin

Outcome Measures

Primary Outcomes (1)

  • Change in Breast Milk Content of Cobalamin (Vitamin B12)

    Vitamin B12 (ng/L) is measured in breast milk by quantitative immunoassay

    Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk

Secondary Outcomes (9)

  • Plasma Cobalamin (Vitamin B12)

    Measured once in a fasting blood sample collected on day 2

  • Plasma Folate

    Measured once in a fasting blood sample collected on day 2

  • Change in Breast Milk Content of Thiamin

    Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk

  • Change in Breast Milk Content of Riboflavin

    Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk

  • Change in Breast Milk Content of Niacin

    Breast milk is collected at every infant feeding on days 2, 3 and 4 and is divided into fore, mid and hind milk

  • +4 more secondary outcomes

Study Arms (1)

Micronutrient supplementation

EXPERIMENTAL

On day 3, all mothers are given a commercial multiple micronutrient supplement (Nutri-Fem) manufactured by Thorne, containing the Recommended Dietary Intake (RDA). On day 4, all mothers are given two commercial multiple micronutrient supplements (Nutri-Fem) manufactured by Thorne, containing twice the Recommended Dietary Intake (RDA).

Dietary Supplement: Multiple micronutrient supplement (Nutri-Fem)

Interventions

Multiple micronutrient supplement (Nutri-Fem)DIETARY_SUPPLEMENT

Multiple micronutrient supplement (Nutri-Fem) manufactured by Thorne, containing the Recommended Dietary Intake (RDA).

Micronutrient supplementation

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \>18.5 Healthy
  • In the 2nd to 4th month of lactation and breastfeeding ≥12 times/d
  • Breast-feeding only one infant
  • Non-pregnant
  • Willing to spend 4 days and nights at the metabolic unit
  • Willing to perform the procedures of BM collection using the breast pump.

You may not qualify if:

  • Severe anemia (Hb \<90 g/L) by HemoCue
  • Currently taking micronutrient supplements
  • Current pregnancy
  • Current illness
  • Current Mastitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Dhaka, Bangladesh

Location

Related Publications (1)

  • Hampel D, Shahab-Ferdows S, Islam MM, Peerson JM, Allen LH. Vitamin Concentrations in Human Milk Vary with Time within Feed, Circadian Rhythm, and Single-Dose Supplementation. J Nutr. 2017 Apr;147(4):603-611. doi: 10.3945/jn.116.242941. Epub 2017 Feb 15.

    PMID: 28202638DERIVED

MeSH Terms

Conditions

Calcinosis

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Lindsay H Allen, PhD

    USDA, Western Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 29, 2016

Study Start

September 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

April 29, 2016

Record last verified: 2016-04

Locations

BA(1)