Growth Disorders Clinical Trial
— TRIUMFOfficial title:
Effect of a Complementary Food Supplement on Growth and Morbidity of Ghanaian Infants (6 to 18 Months)
Verified date | February 2018 |
Source | Nevin Scrimshaw International Nutrition Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1204 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 6 Months |
Eligibility |
Inclusion Criteria: 1. Non pre-term 2. Singleton birth 3. Exclusively or predominantly breast fed up to time of recruitment 4. Parents planning to live in community for a period of 12 months and willing to participate in the trial for the entire period 5. Receive informed consent from both parents and/or caregivers or from mother alone if single Exclusion Criteria: 1. Severely anemic (<7 g/dl) (to be referred to Community Health Post (CHP) for routine care on anemia as recommended by Ghana Health Service) 2. Severely malnourished (MUAC <110 mm) (to be referred to CHP with Community-based Management of Acute Malnutrition (CMAM) protocol) and/or use of CMAM protocol or below -2 standard deviations (SD) weight for age Z score |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Nevin Scrimshaw International Nutrition Foundation | Ajinomoto USA, INC., Ghana Health Services, University of Cape Coast, University of Ghana |
de Pee S, Bloem MW. Current and potential role of specially formulated foods and food supplements for preventing malnutrition among 6- to 23-month-old children and for treating moderate malnutrition among 6- to 59-month-old children. Food Nutr Bull. 2009 Sep;30(3 Suppl):S434-63. Review. — View Citation
Ghana Statistical Service, Ghana Health Service, ICF Macro Ghana Demographic and Health Survey 2008, Accra, Ghana, p 512, 2009
Pan American Health Organization. Guiding Principles for Complementary Feeding of the Breast Fed Child p37, 2003
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in monthly length for age Z-score (monthly LAZ) | Change in length for age Z-score from 6 months to 18 months of age. | Measured on a monthly basis until 18 months of age | |
Secondary | Change in Serum Hemoglobin | Change in serum hemoglobin from baseline to endline (6 months to 18 months) | Baseline (6 months), Midline (12 months of age), Endline (18 months of age) | |
Secondary | Change in Serum retinol binding protein | Change in serum retinol binding protein from baseline to endline (6 months to 18 months) | Baseline (6 months), Midline (12 months of age), Endline (18 months of age) | |
Secondary | Change in serum transferrin receptors | Change from baseline to endline (6 months to 18 months) | Baseline (6 months), Midline (12 months of age), Endline (18 months of age) | |
Secondary | Change in serum ferritin | Change from baseline to endline (6 months to 18 months) | Baseline (6 months), Midline (12 months of age), Endline (18 months of age) | |
Secondary | Change in serum zinc | Change from baseline to endline (6 months to 18 months) | Baseline (6 months), Midline (12 months of age), Endline (18 months of age) | |
Secondary | Change in Weight for age Z-score | This is the change in weight for age Z-score from 6 months to 18 months of age | Measured at baseline and then on a monthly basis for the duration of the intervention (12 months) | |
Secondary | Change in Weight for height Z-score | This is the change in weight for length Z-score from 6 months to 18 months of age | Measured at baseline and then on a monthly basis for the duration of the intervention (12 months) | |
Secondary | Prevalence of diarrhea | Prevalence of diarrhea over a 12 month period (duration of intervention) | Measured at baseline and then in a weekly surveillance for the duration of the intervention (12 months or 52 weeks) | |
Secondary | Prevalence of upper respiratory infections | Prevalence of respiratory infections over a 12 month period (duration of the intervention) | Measured at baseline and then in a weekly surveillance for the duration of the intervention (12 months or 52 weeks) | |
Secondary | Change in serum C-reactive protein | Change from baseline to endline (6 months to 18 months) | Baseline (6 months), Midline (12 months of age), Endline (18 months of age) | |
Secondary | Change in serum alpha glycoprotein | Change from baseline to endline (6 months to 18 months) | Baseline (6 months), Midline (12 months of age), Endline (18 months of age) | |
Secondary | Change in Head Circumference for age | This is the change in head circumference for age from 6 months to 18 months of | Measured at baseline and then on a monthly basis for the duration of the intervention (12 months) | |
Secondary | Change in MUAC (Mid Upper Arm Circumference) | This is the change in MUAC for age from 6 months to 18 months of age | Measured at baseline and then on a monthly basis for the duration of the intervention (12 months) | |
Secondary | Change in Plasma Amino Acid levels | This is the change in individual plasma amino acids from 6 months to 18 months | Baseline (6 months), Midline (12 months of age), Endline (18 months of age) |
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 |