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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00970866
First Posted: September 3, 2009
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, Davis
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 ]
  • 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 ]

Estimated Enrollment: 864
Study Start Date: November 2009
Estimated Study Completion Date: December 2018
Primary Completion Date: March 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Adu-Afarwuah S, Lartey A, Brown KH, Zlotkin S, Briend A, Dewey KG. Randomized comparison of 3 types of micronutrient supplements for home fortification of complementary foods in Ghana: effects on growth and motor development. Am J Clin Nutr. 2007 Aug;86(2):412-20.
Adu-Afarwuah S, Lartey A, Brown KH, Zlotkin S, Briend A, Dewey KG. Home fortification of complementary foods with micronutrient supplements is well accepted and has positive effects on infant iron status in Ghana. Am J Clin Nutr. 2008 Apr;87(4):929-38.
Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Postintervention growth of Malawian children who received 12-mo dietary complementation with a lipid-based nutrient supplement or maize-soy flour. Am J Clin Nutr. 2009 Jan;89(1):382-90. doi: 10.3945/ajcn.2008.26483. Epub 2008 Dec 3.
Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Complementary feeding with fortified spread and incidence of severe stunting in 6- to 18-month-old rural Malawians. Arch Pediatr Adolesc Med. 2008 Jul;162(7):619-26. doi: 10.1001/archpedi.162.7.619. Erratum in: Arch Pediatr Adolesc Med. 2008 Oct;162(10):942.
Kaestel P, Michaelsen KF, Aaby P, Friis H. Effects of prenatal multimicronutrient supplements on birth weight and perinatal mortality: a randomised, controlled trial in Guinea-Bissau. Eur J Clin Nutr. 2005 Sep;59(9):1081-9.
Rivera JA, Martorell R, Ruel MT, Habicht JP, Haas JD. Nutritional supplementation during the preschool years influences body size and composition of Guatemalan adolescents. J Nutr. 1995 Apr;125(4 Suppl):1068S-1077S.
Mora JO, de Paredes B, Wagner M, de Navarro L, Suescun J, Christiansen N, Herrera MG. Nutritional supplementation and the outcome of pregnancy. I. Birth weight. Am J Clin Nutr. 1979 Feb;32(2):455-62.
Super CM, Herrera MG, Mora JO. Long-term effects of food supplementation and psychosocial intervention on the physical growth of Colombian infants at risk of malnutrition. Child Dev. 1990 Feb;61(1):29-49.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Klevor MK, Adu-Afarwuah S, Ashorn P, Arimond M, Dewey KG, Lartey A, Maleta K, Phiri N, Pyykkö J, Zeilani M, Ashorn U. A mixed method study exploring adherence to and acceptability of small quantity lipid-based nutrient supplements (SQ-LNS) among pregnant and lactating women in Ghana and Malawi. BMC Pregnancy Childbirth. 2016 Aug 30;16:253. doi: 10.1186/s12884-016-1039-0.
Adu-Afarwuah S, Lartey A, Okronipa H, Ashorn P, Peerson JM, Arimond M, Ashorn U, Zeilani M, Vosti S, Dewey KG. Small-quantity, lipid-based nutrient supplements provided to women during pregnancy and 6 mo postpartum and to their infants from 6 mo of age increase the mean attained length of 18-mo-old children in semi-urban Ghana: a randomized controlled trial. Am J Clin Nutr. 2016 Sep;104(3):797-808. doi: 10.3945/ajcn.116.134692. Epub 2016 Aug 17.
Prado EL, Adu-Afarwuah S, Lartey A, Ocansey M, Ashorn P, Vosti SA, Dewey KG. Effects of pre- and post-natal lipid-based nutrient supplements on infant development in a randomized trial in Ghana. Early Hum Dev. 2016 Aug;99:43-51. doi: 10.1016/j.earlhumdev.2016.05.011. Epub 2016 Jul 6.
Oaks BM, Laugero KD, Stewart CP, Adu-Afarwuah S, Lartey A, Ashorn P, Vosti SA, Dewey KG. Late-Pregnancy Salivary Cortisol Concentrations of Ghanaian Women Participating in a Randomized Controlled Trial of Prenatal Lipid-Based Nutrient Supplements. J Nutr. 2016 Feb;146(2):343-52. doi: 10.3945/jn.115.219576. Epub 2016 Jan 13.
Klevor MK, Haskell MJ, Lartey A, Adu-Afarwuah S, Zeilani M, Dewey KG. Lipid-Based Nutrient Supplements Providing Approximately the Recommended Daily Intake of Vitamin A Do Not Increase Breast Milk Retinol Concentrations among Ghanaian Women. J Nutr. 2016 Feb;146(2):335-42. doi: 10.3945/jn.115.217786. Epub 2016 Jan 6.
Adu-Afarwuah S, Lartey A, Okronipa H, Ashorn P, Zeilani M, Peerson JM, Arimond M, Vosti S, Dewey KG. Lipid-based nutrient supplement increases the birth size of infants of primiparous women in Ghana. Am J Clin Nutr. 2015 Apr;101(4):835-46. doi: 10.3945/ajcn.114.091546. Epub 2015 Feb 11.

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00970866     History of Changes
Other Study ID Numbers: 200917276
First Submitted: September 1, 2009
First Posted: September 3, 2009
Last Update Posted: August 14, 2017
Last Verified: August 2017

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
Vitamins
Growth Substances
Physiological Effects of Drugs


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