Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04846062 |
| Other study ID # |
IHRPGD/3007/18 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2021 |
| Est. completion date |
December 30, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
Jimma University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Hypotheses of the study
1. Mothers/ caregivers who have less knowledge and attitude about the prevention of IDD
their table salt obtained from in the households has less quantity of iodide than those
mothers/ caregivers who might have knowledge and attitude.
2. Mothers/ caregivers with poor knowledge and attitude in iodized salt utilization
circumstances that their index children have at higher risk of iodine deficiency
compared with their properly utilizes counterparts. linear
3. Children's poor dietary intake has low hemoglobin concentration compared to their peers
who used diversified dietary intake.
4. Children with a low concentration of iodine have stunted growth (linear growth) compared
with their high iodine concentration peers at the end of the follow-up period of fifteen
months.
5. Children with a low concentration of hemoglobin have stunted growth (linear growth)
compared with their high hemoglobin concentration peers at the end of the follow-up
fifteen months.
6. Higher concentrations of micronutrients due affect the growth of children compared with
their higher concentration of micronutrients at the end of the follow-up period of
fifteen months.
Description:
Objective: The aim of this study is to determine effect of BCC on micronutrients intake and
growth of children age 6-59 month old in Arsi Zone highland, Oromiya, Ethiopia.
Chapter 1 knowledge and attitude about the prevention of iodine deficiency disorders among
women and quantification of iodine found in table salt. This chapter presents the
investigation of iodine content in table salts samples obtained from households and
headquarters markets and the women's understanding and approach status about iodine
deficiency disorders.
Chapter 2 Median urinary iodine concentration and associated factors among children age 6 to
59 months; It summarizes the median level of iodide found in children's urine and determined
significant associated factors.
Chapter 3 hemoglobin level and associated factors among children age 6 to 59 months. It
describes predictors of knowledge and attitude about the prevention of iron deficiency anemia
among women and it presents the hemoglobin threshold of children and determines factors.
Chapter 4 effect of NBC on iodised salt utilization and median urine iodine concentration
among the growth of children. This chapter describes the impact of NBC intervention on
iodised salt utilization in the HH, compaction of the endine - baseline difference of median
urine concentration, and its significant association with the growth of children.
Chapter 5 effect of NBC on prevent anemia and hemoglobin concentration among the growth of
children. This chapter describes the impact of NBC on iron-rich dietary intake in the HH.
Also, the chapter described the comparition of endine - baseline mean differences of
hemoglobin concentration, and factors associated with the growth of children.
Chapter 6 micronutrient concentration effects on growth defect among children; this chapter
describes the deference endline - baseline difference of the mean differences in iron and
iodine and concentration association with linear growth of children.
Methods: Community based, clustered randomized controlled trial will be carried out.
Study sample size: The sample size was determined using Gpower 3.0 software assuming a power
of 95%, precision of 5%, and an effect size of 0.25 giving 834. Additionally, we considered
the loss of study participants due to an increase in age of children above 59 months for the
given intervention period was 11% =95. Where the design effect had 10% =83 and a final the
estimated sample size was 1012.
Multistage sampling method was applied to select 16 kebeles [lower administration Units]
randomly and equally assigned into intervention and control clusters using computer ENA 2011
version software. Further, systematic random sampling will be used to select
mothers/caregivers with their children from randomly assigned kebeles Baseline data will be
collected from recruited mothers and from their pair children. Questionnaire on behaviours on
dietary intake of children and micronutrients utilization, and anthropometric data will be
collected; Households' table salt samples will be collected and analyzed with a titration
biomarker in Ethiopian Public health institute food and nutrition laboratory (EPI). Urine
samples for baseline will be collected and transported to EPI and analyzed to determine urine
iodine Concentration (UIC) and this will be applicable at the end line of nutrition behavior
change intervention. Blood samples will be collected to determine hemoglobin level before
after nutrition behavior change intervention implementation.
Data processing and analysis: Anthropometric and other data were entered into EpiData 3.0
version software and transferred and analyzed using the Statistical Package for Social
Science statistical software for Windows, version 21, Anthropometric data will be exported to
Emergency Nutrition Assessment [ENA] software to generate height for age Z-score (HAZ) and
weight for height z-score [WHZ]. HAZ ≥ -2 Z-score will be categorized as normal growth status
and HFA < -2 z-score will be indicated as a growth defect. According to WHO classification, >
40% is very high and 30 to 39% is high and 20 to 29 medium and < 20% is low (22). Also,
weight for height Z score (WHZ) was generated to determine wasting among children (16, 17).
Anthropometric results of children's growth at baseline and end-line surveys were compared
with the WHO 2005 growth standard using ENA software.
Linear regression was used to determine the effect of iron and iodine concentration on the
linear growth of children. Independent sample t test will be used to determine mean
differences between end-line-baseline in micronutrient concentrations (iodine and iron) and
will be compared between intervention and control groups and significance will be determined
with Standard Error (P<0.05) . Finally, independent variables that will have P <0.25 in
samples t-test will be transferred to Generalized Estimating Equations [GEE] for further
analysis and the results presented using Beta coefficients (β) and 95% confidence intervals.
