NCT00970840

Brief Summary

Inadequate micronutrient intakes during pregnancy, lactation and infancy remain a major problem in Ghana. Lipid-based nutrient supplements (LNS) made using vegetable oil, groundnut paste, milk, sugar, and micronutrients may offer a solution. The proposed study will test the acceptability of a lipid-based nutrient supplement designed for infants (LNS-20gM) and another designed for pregnant and lactating women (LNS-P\&L). Participants will consume a test meal consisting of LNS-20gM (20 infants) or LNS-P\&L (20 pregnant and lactating women) mixed with fermented maize porridge, after which they will be given the respective LNS supplement for use at home for 14 d. Primary outcome is the proportion of the test-meal consumed. The investigators hypothesize that subjects will consume at 75% of the test meal offered.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

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

Study Start

First participant enrolled

June 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
Last Updated

March 27, 2017

Status Verified

September 1, 2009

Enrollment Period

Same day

First QC Date

September 1, 2009

Last Update Submit

March 22, 2017

Conditions

Keywords

AcceptabilitySupplementsHome-fortification

Outcome Measures

Primary Outcomes (1)

  • Proportion of test-meal consumed

    One day

Secondary Outcomes (2)

  • Degree of liking for appearance, aroma, flavor and consistency of LNS product mixed with koko

    14 days

  • Amount of LNS consumed during the 14-day study period

    14 days

Study Arms (1)

LNS-20gM or LNS-P&L

EXPERIMENTAL
Dietary Supplement: LNS-20gM or LNS-P&L

Interventions

LNS-20gM or LNS-P&LDIETARY_SUPPLEMENT

Participants consumed a test meal (45 g or 50 g) consisting of LNS-20gM or LNS-P\&L mixed with fermented maize porridge, after which they were provided with the respective LNS supplements for use at home daily for 14 d

LNS-20gM or LNS-P&L

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • months of age
  • currently receiving breast milk
  • has been consuming complementary foods for at least 30 days
  • being ≥ 18 years of age
  • confirmed to be pregnant or breastfeeding

You may not qualify if:

  • intolerance to milk or peanut
  • illness requiring referral

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Martins de Porres Hospital

Agomanya, Ghana

Location

MeSH Terms

Conditions

AnemiaMalnutrition

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Kathryn G. Dewey, PhD

    UC Davis

    STUDY DIRECTOR
  • Anna Lartey, PhD

    University of Ghana

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 1, 2009

First Posted

September 3, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

March 27, 2017

Record last verified: 2009-09

Locations