Overview

This trial is active, not recruiting.

Conditions anemia, malnutrition, stunting
Treatments iron and folic acid (ifa), multiple micronutrient (mmn) group, lipid-based nutrient supplements (lns) group
Sponsor University of California, Davis
Start date November 2009
End date March 2014
Trial size 864 participants
Trial identifier NCT00970866, 200917276-1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose health services research
Arm
(Active Comparator)
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
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
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)
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
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
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)
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
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
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.

Primary Outcomes

Measure
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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Efficacy of Lipid-based Nutrient Supplements (LNS) for Pregnant and Lactating Women and Their Infants
Principal investigator Kathryn G. Dewey, PhD
Description Introduction: Inadequate nutrient intakes during pregnancy remain a major problem worldwide. The standard nutritional intervention during pregnancy is iron-folic acid tablets, but adherence is generally quite low. We have pioneered the use of lipid-based nutrient supplements (LNS), which are multiple micronutrient-fortified semi-solid pastes made using vegetable oil, groundnut paste, milk, sugar, and micronutrients, for home fortification of complementary foods for infants. Given results of previous studies with Nutributter in Ghana (1, 2) and similar LNS in Malawi (3, 4) we believe that the food-based approach using LNS has the potential to improve the nutritional status of these women, and thereby also enhance their children's growth and micronutrient status. Our consortium has formulated LNS-P&L for pregnant and lactating women, and modified the Nutributter for children, which has been called LNS-20gM in this trial. The LNS-20gM provides generally the Recommended Nutrient Intakes (RNI) for 18 vitamins and minerals for infants from 6 to 18 mo of age. The LNS-P&L is modeled on the UNICEF/WHO/UNU international multiple micronutrient preparation (UNIMMAP) for pregnant and lactating women and similar products used in Guinea Bissau (5). Each supplement (20 g/day) will provide 118 kcal/day. Both LNS products (LNS-P&L and LNS-20gM) will, in addition to the multiple micronutrients provided in the MMN, supply energy (118 kcal/d), fat (11 g/d), protein (2.6 g/d), the essential fatty acids linoleic acid (=1.29 g/d) and a-linolenic acid (0.29 to >0.6 g/d), as well as calcium, phosphorus, potassium and magnesium. Objectives The study has two objectives, which are: 1. To evaluate the effect of LNS-P&L on the nutritional status of Ghanaian pregnant and lactating women. 2. To assess the effect of LNS-P&L given to pregnant and lactating women and LNS-20gM provided to children from 6 to 18 mo of age on child growth and micronutrient status. Procedures 1. Recruitment: This study will be a community-based, randomized controlled trial with three intervention groups. Potential subjects will be Ghanaian pregnant women attending usual ante-natal clinics at the Government Hospitals at Atua and Akuse, and the St Martins de Porres Catholic Hospital at Agormanya (Manya Krobo District of Ghana), and the Somanya Polyclinic at Somanya (Yilo Krobo District of Ghana). Enrolment into the study will be done in two steps. First, pregnant women who meet an initial set of criteria will be asked their consent (sign a Screening Consent Form) to participate in a pre-enrolment screening using a Screening Questionnaire. During this screening, which will be conducted at the clinics, results of the routine ante-natal examination already entered in the Ante-natal Cards will be inspected. The screening questionnaire will also collect additional information, such as description of place of residence, not recorded in the Ante-natal cards. Second, women who pass the screening will be contacted in their homes, where we will provide them with additional details of the study and seek their consent for recruitment. If they agree, they will sign a recruitment consent form, and enrolment will be said to be completed. Immediately, we will collect background demographic and socioeconomic information in the home using a Baseline Questionnaire, and schedule the women to come to the laboratory to complete a baseline anthropometric and laboratory assessment (blood and urine sampling, hemoglobin, blood pressure and Ultrasound for gestational age). Pregnant women (n = 864) who have completed the baseline assessments and remain eligible for the study will be randomly assigned (using opaque envelopes with group designations) to one of three groups: (1) Group 1: Iron and Folic Acid, (2) Group 2: Multiple Micronutrient (MMN), and (3) Group 3: Lipid-based Nutrient Supplements (LNS). 2. Follow up: Pregnant women will be followed-up through delivery, up to 6 mo postpartum (i.e. remaining part of pregnancy from time of recruitment + 6 mo of lactation), the infants born to the women will be followed-up from birth to 18 mo of age. Field Workers will visit subjects in their homes biweekly during pregnancy and weekly from birth to 18 mo to provide supplements and collect data on morbidity and adherence. In the case of multiple births by a woman, (e.g. twins or triplets), one baby will be randomly selected immediately after delivery to be the index child from whom infant data and blood samples will be collected. Anthropometric data will be collected from the unselected twin or triplets, and those in Group 3 will receive LNS-20gM (because of the cultural belief that twins and triplets, etc., must be treated the same), but blood samples will not be collected from the unselected child. In case of loss of child/children during or after delivery, the mother will be followed-up until 6 mo postpartum. In case of loss of mother during or after delivery, the baby will be followed-up until 18 mo of age. If any woman in the study is recommended to take additional vitamins and/ or minerals by her physician, we will work with the physician to ensure that any supplement given does not lead to excess intakes. 3. Outcome measures: The study will have two primary outcomes namely: 1. Maternal primary outcome: Birth length, and 2. Child primary outcome: Child length-for-age z-score at 18 mo. Secondary outcomes include: i. Maternal: - Anthropometric status (weight, BMI, mid upper arm circumference and sub- scapular skin-fold thickness) at ~ 36 wk gestation and at 6, 12, and 18 mo postpartum. - Pregnancy outcomes (birth weight, gestational age). - Anemia, micronutrient (iron, vitamin A, B-vitamins, zinc) and EFA status, and malarial antigen at ~ 36 wk gestation and 6 mo postpartum. - Total plasma cholesterol at ~ 36 wk gestation. - Blood pressure and urinary iodine, isoprostane (marker of oxidative stress) and 8-hydroxy-2'deoxyguanosine (8-OHdG) (marker of DNA damage) at 36 wk gestation. - Breast milk composition (EFA, vitamin A, B-vitamins, iodine) at 6 mo postpartum. - Depressive symptoms (which may be related to EFA status) at 6 mo postpartum. ii. Child: - Anthropometric status (weight, length, head circumference and mid upper arm circumference) at birth and 3, 6, 12 and 18 mo. - Anemia, micronutrient (iron, vitamin A, B-vitamins, iodine) and EFA status, and malarial antigen at 6 and 18 mo. - Morbidity between 6 and 18 mo. - Child feeding practices and maternal report of child sleep patterns at 6, 12 and 18 mo. - Energy intake from complementary foods at 9 and 15 mo. - Antibody response to measles vaccination at 12 mo. - Achievement of five motor milestones (sitting without support, standing alone, walking with assistance, walking alone and running) and four other developmental milestones (pronouncing single words like mama / dada, waving goodbye, eating by self, drinking from a cup) from 0 to 18 mo. - Neuro-behavioral development at 18 mo of age.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by University of California, Davis.