Growth Disorders Clinical Trial
Official title:
Effect of a Complementary Food Supplement on Growth and Morbidity of Ghanaian Infants (6 to 18 Months)
Prevention of malnutrition in infants and children requires access and intake of nutritious
food starting at birth with exclusive breastfeeding for the first 6 months of life,
breastfeeding in combination with complementary foods from 6-24 months of age, access to
clean drinking water and sanitation, access to preventive and curative health care (including
prenatal).
In Ghana, the Demographic and Health Survey of 2014 reports rates of stunting, wasting and
underweight in children aged 0-59 months are 28%, 14% and 9% respectively. Furthermore,
height for age starts dropping from age 4-6 months with children aged 6-23 months being more
likely to be stunted (40%) than those below 6 months (4%). Infant and young child feeding
data show that for breast-fed children ranging from 6 months through 35 months of age,
cereals are predominantly the first foods introduced in the diet (6-8 months of age). As the
child grows older, consumption of fruits rich in Vitamin A, other fruits and vegetables and
meat, fish, poultry and eggs are reported by the mothers. The Demographic and Health Survey
(DHS) found that the proportion of breast fed children aged 6-23 months who received a
recommended variety of foods the minimum number of times per day increases with child's age
from 28% in children 6-8 months to 50% in children aged 18-23 months.
The study objective is to examine the effect of providing a macro- and micro-nutrient
fortified complementary food supplement (KokoPlusTM) on growth and nutritional status of
Ghanaian infants.
The current study is a cluster randomized single blind intervention design study with three
study arms that aimed to examine the effect of providing a macro- and micro-nutrient
fortified complementary food supplement (KokoPlus) for a period of 12 months (starting at 6
months of age) on growth and nutritional status of Ghanaian infants at 18 months of age.
KokoPlus was formulated using linear programming methodology based on formative and market
analysis research findings.
The subjects in this cluster-randomized trial are from communities in three districts of the
Central region in Ghana with high rates of moderate and severe acute malnutrition. A total of
38 communities will be randomly assigned to one of three groups using block randomization and
another 11 (randomly selected) will be followed cross sectionally as part of a fourth/non
intervention group (growth monitoring).
The total sample size is 1204. Sample size calculations were based on two outcome measures:
expected reduction in diarrheal morbidity and growth (improvements in height-for-age). Sample
size estimates for detecting a 0.5 cm change in height in children provided a caloric and non
caloric micronutrient supplement using a design effect of 2, power of 0.80, alpha of 0.05 and
assuming an attrition rate of 15%, the required sample size per group was 301.
Mother-infant pairs will be recruited between infant age of 0 to 3 months to participate in
monthly nutrition educations sessions and to encourage the women to continue exclusive breast
feeding across all three groups. At 6 months of age, infants in each of the three groups were
enrolled into the intervention study (upon receipt of informed consent). Data collection
involves baseline, midline and endline measurements in the infants at 6, 12 and 18 months of
age. In addition, participating mother-infant pairs will be visited weekly for delivery of
the supplements and for morbidity monitoring and monthly for the measurement of
anthropometry. Anthropometric measurements include: length (Infant/Child Shorr Height Board;
Weigh and Measure, LLC ), weight (Seca 874 digital scale ), mid-upper arm circumference
(MUAC) (Child MUAC Tape; Weigh and Measure, LLC), subscapular and triceps skinfolds (Holtain
skinfold caliper ),head and chest circumference.
Data collection at baseline, midline and endline included one venous sample (3ml) from the
infant, HemoCue (Model 301) measurement to assess severe anemia (7 <g/dl) with appropriate
referrals as mentioned earlier. Ethylenediaminetetracetic acid (EDTA) Vacutainers (BD ;
catalog number 368841) for whole blood and plasma analyses and Trace Element Serum Separator
Tube Vacutainers (BD; catalog number 368380) for serum analyses will be used for the sample
collection with butterfly needles (21 or 23 gauge). Samples will be immediately placed in a
super cooler tube rack and transported back to the lab within five hours where they were
processed immediately. Questionnaires will be administered to assess socio-economic status,
infant and young child feeding practices, morbidity (past week), household food security
along with a 24 hour diet recall. Data was uploaded daily through cellular network, stored on
Formhub and then Ona organization servers.
The primary outcome of the study is the change in length for age Z-score from 6 to 18 months
of age in infants in the KokoPlus group versus Micronutrient powder group and the Nutrition
Education group. Data calculations included estimating anthropometric indices using the WHO
(World Health Organization) 2006 growth reference charts using the WHO macro in STATA (18),
computing the USAID Food and Nutrition Technical Assistance (FANTA) household insecurity
access scores (HFIAS) (19) maternal body mass index (BMI), dietary diversity scores (20), and
re-coding variables as required to binary and accounting for missing. Infant anthropometric
indices calculated include length for age (LAZ) Z- score, weight for age Z-score (WAZ) and
weight for length (WLZ score).
All analyses are intent to treat. Descriptive statistics (means, medians, standard deviations
and standard errors) were computed. To verify the randomization assumption, any differences
in mean values at baseline across three groups were tested using linear mixed effects
regression analyses accounting for clustering. The effect of the supplement (KokoPlus,
Micronutrients and Nutrition Education group) on different dependent variables across the
intervention period will be tested using mixed effects regression analyses accounting for
clustering and repeated measures. The dependent variables tested included change in LAZ
between baseline and endline (primary outcome), change in LAZ on a monthly basis (primary
outcome 2), change in WAZ, WLZ, serum hemoglobin (unadjusted and adjusted for inflammation),
serum ferritin (unadjusted and adjusted for inflammation), serum zinc, serum cortisol, serum
insulin growth factor-1 (IGF-1), serum retinol binding protein, C-reactive protein and alpha
glycoprotein, prevalence of acute and chronic infection.
A cross-sectional assessment (anthropometry) will be conducted at baseline, midline and
endline in 301 infants that are randomly selected from another set of communities (to be
identified based on the same community selection criteria). These infants will not be
followed longitudinally and the only measurements to be collected include weights and
heights. Informed consent procedures will be similar to the three intervention arms. This
group is a reference group only and cannot be included in any comparative analysis.
Monitoring of groups that receive a supplement will happen weekly. Compliance will be defined
based on the number of supplement packets that are consumed per week. To assure that the
mothers are compliant in using the supplement, they will be asked to return the empty
supplement packages at the end of the week. Optimal compliance will be defined as consumption
of at least 50% of the weekly samples. Supplements will be provided in plastic or paper bags
with a clearly labelled household ID (identity number). Compliance and dose response to
compliance will be reviewed in existing studies to determine minimum compliance required.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01376921 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Spain
|
N/A | |
Completed |
NCT01400997 -
Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Czech Republic
|
N/A | |
Completed |
NCT05244785 -
Health and Nutrition Survey on Shenzhen Children
|
||
Completed |
NCT00097539 -
A Postmarketing Surveillance Program for Nutropin, Nutropin AQ, and Protropin
|
Phase 4 | |
Not yet recruiting |
NCT04576845 -
The Effect of Early Childhood Cow's Milk Allergy Elimination Diet on Eating Behaviors, Nutrition, and Growth Status
|
||
Not yet recruiting |
NCT05056285 -
Pattern of Growth and Characteristics of Down Syndrome Pediatrics Patients
|
||
Completed |
NCT01263457 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in the UK
|
||
Terminated |
NCT00330668 -
Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency
|
Phase 3 | |
Completed |
NCT00378859 -
The Effect of Milk and Meat on IGFs in Prepubertal Boys
|
N/A | |
Not yet recruiting |
NCT05577130 -
Growth Pattern and Characteristics of Cardiac Pediatric Patients
|
||
Recruiting |
NCT05033119 -
PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics
|
||
Completed |
NCT01402999 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Hungary
|
N/A | |
Completed |
NCT01267526 -
A Canadian, Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Pediatric Subjects Using SAIZEN® Via Easypod™ Auto-injector for Growth Hormone Treatment
|
N/A | |
Completed |
NCT00139451 -
Nutrients and Hormones: Effects in Boys With Disordered Growth
|
Phase 2 | |
Terminated |
NCT03274973 -
Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner Syndrome
|
||
Completed |
NCT02015286 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Middle East
|
N/A | |
Completed |
NCT01582334 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Argentina
|
N/A | |
Completed |
NCT01439061 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Italy
|
N/A | |
Completed |
NCT00125164 -
Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency
|
Phase 3 | |
Completed |
NCT00174408 -
Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age
|
Phase 3 |