Anemia Haematological Disorders Anaemia, unspecified
Conditions
Interventions
Current interventions as of 31/10/2014:
Cluster definition:
A cluster in this study is defined as a village in the geographic area of this trial that is randomly alloca
total 48 tablets).
2. Distribution of therapeutic IFA (20 mg/day) 20 tablets/month to the mother/care giver of all anemic children for a total duration of 5 months meant for consumptio
Sponsors
Wellcome Trust/DBT India Alliance (India)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 31/10/2014: Cluster inclusion criteria: A cluster randomized to either study arm will be included in the study if it fulfils the following criteria: 1. Functioning ADC in the village 2. LHW in charge of the ADC willing to participate in the activities detailed in the study 3. LHW attends ADC for at least 75% of the duration of the study Participant inclusion criteria: 1. Age 12-59 months 2. Registration in the village ADC register 3. Residence in a village located in the study site (living in the Chamarajnagar taluk for at least 6 months after enrolment in the trial) 4. Accompanied by mother/care giver who is willing to participate in the study and accept follow-up visits 5. Mother of anemic participants in the intervention arm should be willing to receive LHW-led education, counselling, and monitoring of adherence to iron. Previous inclusion criteria: 1. Documented anemia (hemoglobin 8.0-11.0 gm/dl) 2. Age 1-5 years 3. Residence in a village located in the study site and willingness to participate in the study and follow-up visits
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 31/10/2014: Cluster exclusion criteria: 1. No functioning ADC in the village 2. No LHW in charge of the ADC present in the village to work in ADC or lead intervention 3. LHW unwilling to participate and deliver the intervention Participant exclusion criteria: 1. Severe anemia (Hb = 7.9 gm/dl) ? These children in both the intervention and the control arm will be referred to the primary health centre/first referral unit for assessment and medical management as per guidelines in the National Iron + initiative. After referral, children in the intervention arm although excluded from the trial will be eligible to receive the intervention elements from the LHW described in the trial. 2. Ill health (active infection or fever >101° F) ? These children will be managed as per usual guidelines either by referral to the primary health centre/first referral unit or recommendation to the LHW to inform the mother/care giver to take the child to such a facility in case the mother does not report for the trial/is unavailable. Previous exclusion criteria: 1. Children with severe anemia (hemoglobin = 7.9 gm/dl) 2. Children who are unwell (active infection or fever >101 ° F) will be referred to the local primary health centre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 31/10/2014: The primary outcome will be the difference between experimental groups in the prevalence of anemia among children found to be anemic at baseline, as detected at the end of 6 months and the net improvement in individual hemoglobin values in gm/dl (difference of baseline and 6-month values). Previous primary outcome measures: Hemoglobin value collected at baseline and after 6 months of participation in the trial, expressed in g/dl. Haemoglobin measured by the automated cell counter (cyanmethhemoglobin). | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 31/10/2014: These include: 1. Difference in anemia prevalence at the level of each cluster in the two arms at the conclusion of the trial (6 months after the intervention begins) 2. Difference in anemic participants mean ferritin value (an index of iron stores) between experimental arms at the conclusion of the trial (6 months after the intervention begins) 3. Difference in the 24 hr dietary iron intake of all participants between baseline and post intervention assessments in the two experimental arms 4. Change in mothers? knowledge and practices between baseline and 6 months follow up for all children in the two arms of the study 5. The proportion of child-delivered IFA doses (adherence to iron treatment) 6. Incidence of side effects of IFA supplements in children Previous secondary outcome measures: 1. Individual serum ferritin levels (ng/ml) measured at baseline and after 6 months 2. Adherence to iron and folic acid measured with an adherence questionnaire using self-reporting (30-day visual analog scale) and objective pill count methods assessed every month in both arms 3. Dietary iron intake (mg/24hrs) assessed at baseline and after 6 months 4. Mothers' knowledge about anemia at baseline and after 6 months 5. Fidelity measures to capture delivery of the intervention by assessing audits, log books and trial registry information, measured at baseline and monthly for 6 months 6. Qualitative studies will be performed at the end of the trial | — |
Countries
India
Outcome results
None listed