Acceptability of Nutrient Supplements Among Women and Children in Bangladesh

NCT01129089 | Completed

• 2 other identifiers: 2739184001-UCD-00
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to confirm the acceptability of lipid-based nutrient supplements (LNS) for use as nutritional supplements for pregnant and lactating women (PLW) or infants and young children (IYC) and micronutrient powder (MNP) for use as nutritional supplements for infants and young children in Bangladesh.We hypothesized that at least 75 percent of the test dose of LNS and MNP offered to PLW and IYC will be consumed by them.

Conditions

Malnutrition

Keywords

Acceptability; Lipid-based nutrient supplements; Micronutrient powder; Malnutrition

Outcome Measures

Primary Outcomes (2)

• Proportion of test dose consumed

  Mean consumption of the test dose of LNS for PLW, LNS for IYC and MNP for IYC on day 2 (First test dose)

  Day 2

• Proportion of test dose consumed

  Mean consumption of the test dose of LNS for PLW, LNS for IYC and MNP for IYC on day 3(Second test dose)

  Day 3

Secondary Outcomes (4)

• Proportion of subjects liked the supplements

  Day 2

• Proportion of subjects liked the supplement

  Day 3

• Proportion of subjects liked the supplement

  Day 8

• Proportion of subjects liked the supplement

  Day 15

Study Arms (3)

LNS-PLW

EXPERIMENTAL

There will be 48 pregnant or lactating women (PLW) in this arm. They will be randomized to receive cumin flavored LNS-PLW or LNS-PLW with no added flavor on day 2. On day 3, the PLW getting a test-dose of cumin flavored LNS-PLW on day 2 will receive LNS-PLW with no added flavor and the PLW getting a test-dose of LNS-PLW with no added flavor on day 2 will receive cumin flavored LNS-PLW.

Dietary Supplement: Lipid-based nutrient supplement

LNS-Child

EXPERIMENTAL

There will be 48 infant and young children(IYC) in this arm. They will be randomized to receive cardamom flavored LNS-Child or LNS-Child with no added flavor on day 2. On day 3, the IYC getting a test-dose of LNS-Child with no added flavor on day 2 will receive cardamom flavored LNS-Child and the IYC getting a test-dose of cardamom flavored LNS-Child on day 2 will receive LNS-Child with no added flavor.

Dietary Supplement: Lipid-based nutrient supplement

MNP-Child

EXPERIMENTAL

There will be 48 infant and young children(IYC) in this arm. They will receive MNP on day 2 and day 3.

Dietary Supplement: Micronutrient powder

Interventions

Lipid-based nutrient supplement DIETARY_SUPPLEMENT

Lipid-based nutrient supplement for pregnant and lactating women

Also known as: LNS

LNS-PLW

Micronutrient powder DIETARY_SUPPLEMENT

Micronutrient powder for infant and young children

Also known as: MNP, Sprinkles

MNP-Child

Eligibility Criteria

• Age: 6 Months - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women in their second or third trimester (in case of third trimester pregnancy, the expected date of delivery is not within three weeks) or lactating women with a child between 3 days and 6 months of age
• At least 18 years of age
• No life-threatening pregnancy-related complications (e.g., pre-eclampsia, antepartum hemorrhage)
• Apparently healthy and not presently suffering from an acute illness (e.g., fever, diarrhea, acute respiratory tract infection)
• Living in the study area for at least 6 months
• Planning to remain in study area for at least the following three weeks.

You may not qualify if:

• Known allergy to peanuts or other food products (as reported on the screening questionnaire)
• Children 6-24 months of age
• Consuming solid foods for at least the past 30 days
• Apparently healthy and not presently suffering from an acute illness (e.g., fever, diarrhea, acute respiratory tract infection)
• No known allergy to peanuts or other food products (as reported on the screening questionnaire by the mother/primary caregiver)\[LNS-Child only\]
• Planning to remain in study area for at least the following three weeks.
• Severely malnourished \[mid-upper arm circumference (MUAC) \< 115 mm\]

Sponsors & Collaborators

• University of California, Davis: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Fatejangpur

Chirirbandar, Dinajpur, 5240, Bangladesh

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Katnryn G Dewey, Ph.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Malay K Mridha, MBBS,MPH

  University of Callifornia, Davis

  STUDY DIRECTOR

• Camila M Chaparro, Ph.D.

  Academy for Educational Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: May 24, 2010
• Study Start: December 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

BA (1)