Efficacy of Lipid-Based Nutrient Supplements (LNS) for Pregnant and Lactating Women and Their Infants

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00970866
First received: September 1, 2009
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

In Ghana, low micronutrient intakes among pregnant women are a major problem. The standard nutritional intervention during pregnancy is iron-folic acid tablets, but adherence is low. The investigators have pioneered the use of multiple micronutrient-fortified semi-solid pastes called Lipid-based Nutrient Supplements (LNS) (made using vegetable oil, groundnut, milk, sugar, and micronutrients), and the investigators' previous studies show that the approach could have great potential for use by pregnant and lactating women.

This study aims to evaluate the effects of LNS-P&L designed for pregnant and lactating women and LNS-20gM designed for infants. Pregnant women (n=864) randomly selected from ante-natal clinics in Yilo and Manya Krobo districts of Ghana will be randomized to receive daily (a) Group 1: Iron/ Folic Acid tablets during pregnancy, and a tablet containing calcium (Ca) only (akin to a placebo) during lactation (6 mo), (b) Group 2: Multiple Micronutrient tablets during pregnancy and the first six months of lactation, or (c) Group 3: LNS-P&L during pregnancy and lactation, whilst their infants receive LNS-20gM daily from 6 to 18 months. There are two primary outcomes namely:

  1. Maternal primary outcome: Birth length
  2. Child primary outcome: Child length-for-age z-score at 18 mo.

The investigators hypothesize that a) mean birth length and length-for-age at 18 mo will be greater in children whose mothers are in Group 2 than those whose mothers are in Group 1, and b) children whose mothers are in Group 3 will have greater birth length and length-for-age at 18 mo than the children in either of the other two groups.


Condition Intervention
Anemia
Malnutrition
Stunting
Dietary Supplement: Iron and Folic Acid (IFA)
Dietary Supplement: Multiple Micronutrient (MMN) group
Dietary Supplement: Lipid-based Nutrient Supplements (LNS) group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Efficacy of Lipid-based Nutrient Supplements (LNS) for Pregnant and Lactating Women and Their Infants

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Maternal primary outcome is child length at birth [ Time Frame: 0 - 48 hr after birth ] [ Designated as safety issue: No ]
  • Child primary outcome is child length-for-age Z-score (LAZ, based on WHO 2006 growth standards) at 18 months of age [ Time Frame: 18 months after birth ] [ Designated as safety issue: No ]

Estimated Enrollment: 864
Study Start Date: November 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Iron and Folic Acid (IFA) Dietary Supplement: Iron and Folic Acid (IFA)
Pregnant women will receive one (1) Iron (60 mg) and Folic Acid (400 mcg) (IFA) tablet daily during pregnancy, and a tablet containing calcium (Ca) only (akin to a placebo) during lactation; there will be no supplementation for infants born to the women. The Fe/FA tablets will be taken each day with water after meals
Dietary Supplement: Multiple Micronutrient (MMN) group
Pregnant women will receive one (1) Multiple Micronutrient tablet daily during pregnancy and the first 6 months of lactation; there will be no supplementation for infants born to the women. The MMN tablets will be taken each day with water after meals
Dietary Supplement: Lipid-based Nutrient Supplements (LNS) group

Pregnant women will receive 20 g of LNS-P&L daily during pregnancy and the first 6 months of lactation, whilst infants born to the women will receive 20 g of LNS-20gM daily from 6 to 18 mo of age.

The LNS products (LNS-P&L and LNS-20gM) will be consumed by being added to prepared food (usually mixed with complementary foods, for the child). Mothers will consume the full sachet of LNS (20 g/day) at one meal each day. Dosage and directions for use of the LNS product for children will be as follows: 20 g (~4 teaspoons) per day divided into 2 portions and consumed at two different times of the day (2 x 2 teaspoons). Mix the portion of the supplement to be consumed with 2-3 tablespoons of the already prepared food (as done previously in our study in Ghana (1)), and eat the mixture before eating the rest of the food. Do not cook food with the supplement. Store supplement at room temperature. There is no need for refrigeration.

Active Comparator: Multiple Micronutrient (MMN) Dietary Supplement: Iron and Folic Acid (IFA)
Pregnant women will receive one (1) Iron (60 mg) and Folic Acid (400 mcg) (IFA) tablet daily during pregnancy, and a tablet containing calcium (Ca) only (akin to a placebo) during lactation; there will be no supplementation for infants born to the women. The Fe/FA tablets will be taken each day with water after meals
Dietary Supplement: Multiple Micronutrient (MMN) group
Pregnant women will receive one (1) Multiple Micronutrient tablet daily during pregnancy and the first 6 months of lactation; there will be no supplementation for infants born to the women. The MMN tablets will be taken each day with water after meals
Dietary Supplement: Lipid-based Nutrient Supplements (LNS) group

Pregnant women will receive 20 g of LNS-P&L daily during pregnancy and the first 6 months of lactation, whilst infants born to the women will receive 20 g of LNS-20gM daily from 6 to 18 mo of age.

The LNS products (LNS-P&L and LNS-20gM) will be consumed by being added to prepared food (usually mixed with complementary foods, for the child). Mothers will consume the full sachet of LNS (20 g/day) at one meal each day. Dosage and directions for use of the LNS product for children will be as follows: 20 g (~4 teaspoons) per day divided into 2 portions and consumed at two different times of the day (2 x 2 teaspoons). Mix the portion of the supplement to be consumed with 2-3 tablespoons of the already prepared food (as done previously in our study in Ghana (1)), and eat the mixture before eating the rest of the food. Do not cook food with the supplement. Store supplement at room temperature. There is no need for refrigeration.

Active Comparator: Lipid-based Nutrient Supplements (LNS) Dietary Supplement: Iron and Folic Acid (IFA)
Pregnant women will receive one (1) Iron (60 mg) and Folic Acid (400 mcg) (IFA) tablet daily during pregnancy, and a tablet containing calcium (Ca) only (akin to a placebo) during lactation; there will be no supplementation for infants born to the women. The Fe/FA tablets will be taken each day with water after meals
Dietary Supplement: Multiple Micronutrient (MMN) group
Pregnant women will receive one (1) Multiple Micronutrient tablet daily during pregnancy and the first 6 months of lactation; there will be no supplementation for infants born to the women. The MMN tablets will be taken each day with water after meals
Dietary Supplement: Lipid-based Nutrient Supplements (LNS) group

Pregnant women will receive 20 g of LNS-P&L daily during pregnancy and the first 6 months of lactation, whilst infants born to the women will receive 20 g of LNS-20gM daily from 6 to 18 mo of age.

The LNS products (LNS-P&L and LNS-20gM) will be consumed by being added to prepared food (usually mixed with complementary foods, for the child). Mothers will consume the full sachet of LNS (20 g/day) at one meal each day. Dosage and directions for use of the LNS product for children will be as follows: 20 g (~4 teaspoons) per day divided into 2 portions and consumed at two different times of the day (2 x 2 teaspoons). Mix the portion of the supplement to be consumed with 2-3 tablespoons of the already prepared food (as done previously in our study in Ghana (1)), and eat the mixture before eating the rest of the food. Do not cook food with the supplement. Store supplement at room temperature. There is no need for refrigeration.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • No more than 20 wk of gestation
  • Given Ante-natal Cards of the Ghana Health Service
  • Completed the initial routine ante-natal examination at the clinics
  • HIV negative or status unknown (as from the Ante-natal card)
  • Free from chronic disease e.g. malignancy requiring frequent medical attention (as from the Ante-natal card)
  • Residing in the Manya Krobo or Yilo Krobo district
  • Prepared to sign an informed consent
  • Living in the area throughout the duration of the study
  • Acceptance of home visitors

Exclusion Criteria:

  • Known asthmatic or history of allergy towards peanut or milk products
  • Concurrent participation in another clinical trial
  • Severe illness warranting hospital referral
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970866

Locations
Ghana
St. Martin de Porre's Hospital
Agomanya, Ghana
Atua Government Hospital
Atua, Ghana
Kpong Reproductive and Child Health (RCH) Center
Kpong, Ghana
Somanya Polyclinic
Somanya, Ghana
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Kathryn G. Dewey, PhD UC Davis
Principal Investigator: Anna Lartey, PhD University of Ghana, Legon
  More Information

Publications:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00970866     History of Changes
Other Study ID Numbers: 200917276-1
Study First Received: September 1, 2009
Last Updated: January 5, 2012
Health Authority: Ghana: Ministry of Health

Keywords provided by University of California, Davis:
multiple micronutrients
home fortification
complementary foods
infant feeding
lipid-based nutrient supplements

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Folic Acid
Vitamin B Complex
Micronutrients
Trace Elements
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014