| CTRI Number |
CTRI/2020/10/028298 [Registered on: 08/10/2020] Trial Registered Prospectively |
| Last Modified On: |
07/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical
Other (Specify) [Multiple micronutrient supplement] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to document the effect of daily supplementation with micronutrients along with iron folic acid, compared to iron folic acid alone, on cure rate from anaemia and on haemoglobin concentration, in children aged 6 to 59 months of age with mild to moderate degree of anaemia |
|
Scientific Title of Study
|
Effect of daily therapeutic supplementation with multiple micronutrients and iron folic acid compared to iron folic acid alone in mild to moderate anemic children aged 6 to 59 months on anaemia cure and haemoglobin concentration: A randomized controlled trial in rural Haryana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravi Prakash Upadhyay |
| Designation |
Research scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
Centre for Health Research and Development, Society for Applied Studies, 45 Kalu Sarai, New Delhi, India
South
DELHI
110016
India |
| Phone |
|
| Fax |
|
| Email |
ravi.upadhyay@sas.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Prakash Upadhyay |
| Designation |
Research scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
Centre for Health Research and Development, Society for Applied Studies, 45 Kalu Sarai, New Delhi, India
South
DELHI
110016
India |
| Phone |
|
| Fax |
|
| Email |
ravi.upadhyay@sas.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Taneja |
| Designation |
Senior Research Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
Centre for Health Research and Development, Society for Applied Studies, 45 Kalu Sarai, New Delhi, India
South
DELHI
110016
India |
| Phone |
|
| Fax |
|
| Email |
sunita.taneja@sas.org.in |
|
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Source of Monetary or Material Support
|
| The study is funded by Indian Council of Medical Research (ICMR) |
|
|
Primary Sponsor
|
| Name |
Centre for Health Research and Development Society for Applied Studies |
| Address |
Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, Near IIT Delhi, South Delhi-110016, India |
| Type of Sponsor |
Other [Not for profit research organization] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravi Prakash Upadhyay |
Centre for Health Research and Development, Society for Applied Studies |
Centre for Health Research and Development, Society for Applied Studies, Jatola-Asaoti Road, District Palwal, Haryana
Faridabad
HARYANA |
011-46043751-55
011-46043756
ravi.upadhyay@sas.org.in |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics review committee, Society for Applied Studies |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D539||Nutritional anemia, unspecified, (2) ICD-10 Condition: D539||Nutritional anemia, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Supplementation with iron folic acid |
Daily supplementation with iron folic acid
for 90 days |
| Intervention |
Supplementation with multiple micronutrients along with iron folic acid |
Daily supplementation for 90 days with micronutrients relevant for erythropoiesis (zinc, vitamins B1, B2, B3, B5, B6, B12, A, C, E and D) along with iron folic acid |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
59.00 Month(s) |
| Gender |
Both |
| Details |
Children aged 6-59 months, residing in rural areas of Palwal district, with mild to moderate anaemia
1. Children who are aged 6-59 months
2. Mild to moderate anaemia at enrolment (Hb ≥7 g/dl and <11g/dl)
3. Consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. No Anemia (Hb ≥11g /dL)
2. Severe anemia (Hb <7g/dL)
3. Documented haemoglobinopathy
4. History of repeated blood transfusions and chronic or systemic illnesses
5. Mid-upper arm circumference (MUAC) of <11.5cm
6. Family do not intend to stay in the study area for the duration of the intervention.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Mean haemoglobin concentration
Proportion of children cured of anemia (i.e. Hb ≥11 g/dl)
|
The outcomes will be measured around a week after completion of 90 days supplementation period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Laboratory parameters in a sub-sample
1. Serum ferritin (ng/ml)
2. Serum transferrin receptor (mg/l)
3. Percent transferrin saturation
4. Total iron binding capacity (mcg/dl)
5. Serum transferrin receptor to Serum ferritin ratio
6. Micronutrient (Serum Vitamin B12, Zinc and Folate) concentrations in blood and proportion deficient
7. High sensitive C-reactive protein (hs-CRP)
|
The outcomes will be measured around a week after completion of 90 days supplementation period |
| Cost-effective analysis of supplementing iron folic acid with multiple micronutrients compared to iron folic acid alone |
The analysis will be conducted once the supplementation period of 90 days is over and data on outcomes are available |
|
|
Target Sample Size
|
Total Sample Size="1300"
Sample Size from India="1300"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/10/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
The proposed individually randomized open label trial aims to evaluate the effect of daily supplementation, for 90 days, of erythropoiesis-relevant micronutrients (zinc, vitamins B1, B3, B5, B2, B12, B6, A, C, E and D) in addition to iron folic acid (IFA) in comparison with IFA alone, in children aged 6 to 59 months with mild to moderate anaemia, on anaemia cure rate and haemoglobin concentration. Other outcomes (secondary outcomes) will be assessed in a sub-sample of study children and include serum ferritin, serum transferrin receptor, total iron binding capacity, percent transferrin saturation, micronutrient levels and levels of inflammatory markers (hs-CRP). We also propose to perform a cost effectiveness analysis. Micronutrient (Serum Vitamin B12, Zinc and Folate) levels in blood and proportion deficient, serum hepcidin and hs-CRP will be assessed in a randomly selected sub-sample of children at baseline. The study question emerged from a national consultation facilitated by the Indian Council of Medical Research (ICMR), an apex body in India for formulation, coordination and promotion of biomedical research, because of the growing concern of the national government that the rate of decline in burden of childhood anemia is quite slow.
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