DevelopmentPhase 3NCT02319499
Zinc, Iron, Vitamin A and Psychosocial Care for Child Growth and Development
A Phase 3 study testing Zinc Alone, Iron and Zinc and Iron, Zinc and Vitamin A in people with Development and Iron Deficiency, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Many Indonesian infants are already iron deficient before they reach the age of six months, which also determines the high prevalence of anemia among under-five children. Iron deficiency ultimately leads to anemia, and there is clear evidence that iron deficiency anemia during early childhood has a marked negative… Read more about this study
- Who is it for?
- Ages 3 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Development, Iron Deficiency, Zinc Deficiency
- What is being tested?
- Zinc Alone, Iron and Zinc and Iron, Zinc and Vitamin A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteIndonesia
- Study dates
- Aug 1998to Feb 1999
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3 to 6 month old
- predominantly breast-fed children (assuming the infants were already introduced complementary feedings as early as 4 months)
- parental consent
Who cannot join
- apparent congenital abnormalities
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition (SEAMEO-RECFON)
Jakarta, Java, 10430
About this study
Official title: Zinc, Iron and Vitamin A Supplementation for Infant Growth and Development, and the Contributing Role of Psychosocial Care
Many Indonesian infants are already iron deficient before they reach the age of six months, which also determines the high prevalence of anemia among under-five children. Iron deficiency ultimately leads to anemia, and there is clear evidence that iron deficiency anemia during early childhood has a marked negative effect on child development and cognitive function (Lozoff et al.1991; Idjradinata \& Pollitt, 1993). This negative impact on childhood development is one of the main reasons why iron deficiency during infancy should be prevented or treated.
Since diets low in iron is usually also low in zinc, zinc deficiency --which has negative consequence on growth-- is common in iron deficiency area. In Southeast Asia, the condition is exacerbated by the rich phytate content in the complementary foods which inhibits the absorption of iron as well as zinc (Gibson, 1994). Thus, combining both iron and zinc, hence, is expected to decrease both iron and zinc deficiencies and hence improve growth and development of the children.
Read more
Recently, there has been an emerging view which looks at the two-way relationship between nutrition, health, and psychosocial well-being. This concept is supported by studies on "positive deviance", a term used to refer to children who grow and develop well in impoverished environments where most children are victims of malnutrition and chronic illness (Zeitlin et al., 1990). The mechanism which helps to explain how psychosocial factors, such as the affect between mother and child, are associated with adequate growth and development: 'Psychological stress has a negative effect on the use of nutrients whereas psychological well-being stimulates the secretion of growth-promoting hormones. Pleasantly stimulating interactions can enhance the child's tendency to exercise its developing organ systems and hence to utilize nutrients for growth and development'.
Understanding how the psychosocial environment can promote or inhibit the benefit of supplementation intervention is necessary in order to have a better way of setting about providing supplements. In fact, many supplementation programs do not incorporate complementary program elements that would help to improve the health and psychosocial development of children at the same time that they improve nutritional status' (Myers, 1995). Looking from this perspective, not only will supplementation benefit the psychosocial development but also the psychosocial environment can promote the benefit of the supplementation on the nutritional status and developmental outcomes of infants.
The purpose of the study is to investigate whether multi-micronutrient supplementations (zinc+iron, zinc+iron+vit.A) have positive effect on infants' growth and developmental outcomes, and whether the effect is modified by psychosocial care.
- Conditions
- Development, Iron Deficiency, Zinc Deficiency
- Being tested
- Zinc Alone, Iron and Zinc, Iron, Zinc and Vitamin A, Placebo
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc AloneDietary supplement
Zn-alone group received 10 mg/day of elemental zinc (as zinc sulphate)
Iron and ZincDietary supplement
Zn+Fe group received 10 mg/day of elemental zinc (as zinc sulphate) and 10 mg/day of elemental iron (as ferrous sulphate)
Iron, Zinc and Vitamin ADietary supplement
Zn+Fe+vit.A group received 10 mg/day of elemental zinc (as zinc sulphate) and 10 mg/day of elemental iron (as ferrous sulphate), plus 1,000 IU/day of vitamin A
PlaceboOther
Placebo group received no minerals/vitamin
| Study group | Role | What they receive |
|---|---|---|
| Zinc Alone | Experimental | Zinc Sulphate (10 mg Zn/day) Receives: Dietary Supplement: Zinc Alone |
| Iron and Zinc | Experimental | Ferrous Sulphate and Zinc Sulphate (10 mg/day of each zinc and iron) Receives: Dietary Supplement: Iron and Zinc |
| Iron, Zinc and Vitamin A | Experimental | Ferrous Sulphate, Zinc Sulphate and Vitamin A (10 mg/day of each zinc and iron, plus 1,000 IU vitamin A/day) Receives: Dietary Supplement: Iron, Zinc and Vitamin A |
| Placebo | Placebo comparator | No minerals/vitamin Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Length-for-Age Z-scores
Length-for-Age Z-score
Measured: Baseline and monthly thereafter until endline (6 month of intervention)
Change in Weight-for-Length Z-scores
Weight-for-Length Z-score
Measured: Baseline and monthly thereafter until endline (6 month of intervention)
Change in Weight-for-Age Z-scores
Weight-for-Age Z-scores
Measured: Baseline and monthly thereafter until endline (6 month of intervention)
Changes in Mental Development Index
MDI of Bayley Scale of Infant Development II
Measured: Baseline and Endline (6 month of intervention)
Changes in Psychomotor Development Index
PDI of Bayley Scale of Infant Development II
Measured: Baseline and Endline (6 month of intervention)
Secondary outcomes (4)
Changes in Hemoglobin
measured for all subjects (200 per group)
Measured: Baseline and Endline (6 month of intervention)
Changes in serum zinc
measured in sub-samples (65 subjects/group)
Measured: Baseline and Endline (6 month of intervention)
Changes in serum ferritin
measured in sub-samples (65 subjects/group)
Measured: Baseline and Endline (6 month of intervention)
Changes in serum retinol
measured in sub-samples (65 subjects/group)
Measured: Baseline and Endline (6 month of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startAug 1998
- Primary completionFeb 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for DevelopmentStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umi Fahmida, Universitas Indonesia
- Investigators
- Umi Fahmida, PhD, Principal investigator, South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition (SEAMEO-RECFON)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319499
- Sponsor's protocol ID
- ZIAP
- Status last verified
- Dec 2014
- First submitted
- 7 Dec 2014
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Schultink W, Gross R. Iron deficiency alleviation in developing countries. Nutr Res Rev. 1996 Jan;9(1):281-93. doi: 10.1079/NRR19960015. No abstract available.
PubMed 19094274Colomer J, Colomer C, Gutierrez D, Jubert A, Nolasco A, Donat J, Fernandez-Delgado R, Donat F, Alvarez-Dardet C. Anaemia during pregnancy as a risk factor for infant iron deficiency: report from the Valencia Infant Anaemia Cohort (VIAC) study. Paediatr Perinat Epidemiol. 1990 Apr;4(2):196-204. doi: 10.1111/j.1365-3016.1990.tb00638.x.
PubMed 2362876Lozoff B, Brittenham GM, Wolf AW, McClish DK, Kuhnert PM, Jimenez E, Jimenez R, Mora LA, Gomez I, Krauskoph D. Iron deficiency anemia and iron therapy effects on infant developmental test performance. Pediatrics. 1987 Jun;79(6):981-95.
PubMed 2438638Idjradinata P, Pollitt E. Reversal of developmental delays in iron-deficient anaemic infants treated with iron. Lancet. 1993 Jan 2;341(8836):1-4. doi: 10.1016/0140-6736(93)92477-b.
PubMed 7678046Brown KH, Wuehler SE and Peerson JM (2001). The importance of zinc in human nutrition and estimation of the global prevalence of zinc deficiency. Food Nutr Bull 22 (2):113-25
Gibson RS and Ferguson EL (1999). An Interactive 24-hour Recall for Assessing the Adequacy of Iron and Zinc Intakes in Developing Countries. ILSI Press, Washington DC
Ronaghy HA, Reinhold JG, Mahloudji M, Ghavami P, Fox MR, Halsted JA. Zinc supplementation of malnourished schoolboys in Iran: increased growth and other effects. Am J Clin Nutr. 1974 Feb;27(2):112-21. doi: 10.1093/ajcn/27.2.112. No abstract available.
PubMed 4591425Walravens PA, Chakar A, Mokni R, Denise J, Lemonnier D. Zinc supplements in breastfed infants. Lancet. 1992 Sep 19;340(8821):683-5. doi: 10.1016/0140-6736(92)92229-9.
PubMed 1355797Umeta M, West CE, Haidar J, Deurenberg P, Hautvast JG. Zinc supplementation and stunted infants in Ethiopia: a randomised controlled trial. Lancet. 2000 Jun 10;355(9220):2021-6. doi: 10.1016/S0140-6736(00)02348-5.
PubMed 10885352Rosado JL, Lopez P, Munoz E, Martinez H, Allen LH. Zinc supplementation reduced morbidity, but neither zinc nor iron supplementation affected growth or body composition of Mexican preschoolers. Am J Clin Nutr. 1997 Jan;65(1):13-9. doi: 10.1093/ajcn/65.1.13.
PubMed 8988907Cavan KR, Gibson RS, Grazioso CF, Isalgue AM, Ruz M, Solomons NW. Growth and body composition of periurban Guatemalan children in relation to zinc status: a longitudinal zinc intervention trial. Am J Clin Nutr. 1993 Mar;57(3):344-52. doi: 10.1093/ajcn/57.3.344.
PubMed 8438768Bates CJ, Evans PH, Dardenne M, Prentice A, Lunn PG, Northrop-Clewes CA, Hoare S, Cole TJ, Horan SJ, Longman SC, et al. A trial of zinc supplementation in young rural Gambian children. Br J Nutr. 1993 Jan;69(1):243-55. doi: 10.1079/bjn19930026.
PubMed 8457531Engle P and Ricciuti HN (1995). Psychosocial aspects of care and nutrition. Food Nutr Bull 16(4):356-77
Myers R (1995). The Twelve Who Survive: Strengthening Programmes of Early Childhood Development in the Thirld World. High/Scope Press, Michigan
Bayley (1993). Bayley Scales of Infant Development: Manual, 2nd ed. Harcourt Brace & Co., San Antonio
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc, Iron and Vitamin A Supplementation for Infant Growth and Development, and the Contributing Role of Psychosocial Care
- ClinicalTrials.gov ID
- NCT02319499
- Acronym / sponsor ID
- ZIAP
- Conditions
- Development, Iron Deficiency, Zinc Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Aug 1998
- Primary completion
- Feb 1999 (actual)
- First posted
- 18 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many Indonesian infants are already iron deficient before they reach the age of six months, which also determines the high prevalence of anemia among under-five children. Iron deficiency ultimately leads to anemia, and there is clear evidence that iron deficiency anemia during early childhood has a marked negative effect on child development and cognitive function (Lozoff et al.1991; Idjradinata \& Pollitt, 1993). This negative impact on childhood development is one of the main reasons why iron deficiency during infancy should be prevented or treated.
Since diets low in iron is usually also low in zinc, zinc deficiency --which has negative consequence on growth-- is common in iron deficiency area. In Southeast Asia, the condition is exacerbated by the rich phytate content in the complementary foods which inhibits the absorption of iron as well as zinc (Gibson, 1994). Thus, combining both iron and zinc, hence, is expected to decrease both iron and zinc deficiencies and hence improve growth and development of the children.
Recently, there has been an emerging view which looks at the two-way relationship between nutrition, health, and psychosocial well-being. This concept is supported by studies on "positive deviance", a term used to refer to children who grow and develop well in impoverished environments where most children are victims of malnutrition and chronic illness (Zeitlin et al., 1990). The mechanism which helps to explain how psychosocial factors, such as the affect between mother and child, are associated with adequate growth and development: 'Psychological stress has a negative effect on the use of nutrients whereas psychological well-being stimulates the secretion of growth-promoting hormones. Pleasantly stimulating interactions can enhance the child's tendency to exercise its developing organ systems and hence to utilize nutrients for growth and development'.
Understanding how the psychosocial environment can promote or inhibit the benefit of supplementation intervention is necessary in order to have a better way of setting about providing supplements. In fact, many supplementation programs do not incorporate complementary program elements that would help to improve the health and psychosocial development of children at the same time that they improve nutritional status' (Myers, 1995). Looking from this perspective, not only will supplementation benefit the psychosocial development but also the psychosocial environment can promote the benefit of the supplementation on the nutritional status and developmental outcomes of infants.
The purpose of the study is to investigate whether multi-micronutrient supplementations (zinc+iron, zinc+iron+vit.A) have positive effect on infants' growth and developmental outcomes, and whether the effect is modified by psychosocial care.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Zinc Alone | Experimental | Dietary Supplement: Zinc AloneZinc Sulphate (10 mg Zn/day) |
| Iron and Zinc | Experimental | Dietary Supplement: Iron and ZincFerrous Sulphate and Zinc Sulphate (10 mg/day of each zinc and iron) |
| Iron, Zinc and Vitamin A | Experimental | Dietary Supplement: Iron, Zinc and Vitamin AFerrous Sulphate, Zinc Sulphate and Vitamin A (10 mg/day of each zinc and iron, plus 1,000 IU vitamin A/day) |
| Placebo | Placebo comparator | Other: PlaceboNo minerals/vitamin |
Who may qualify
- Ages
- 3 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 3 to 6 month old
- predominantly breast-fed children (assuming the infants were already introduced complementary feedings as early as 4 months)
- parental consent
Key exclusion criteria (1 listed)
- apparent congenital abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc AloneZn-alone group received 10 mg/day of elemental zinc (as zinc sulphate) | Dietary supplement | Zinc Alone |
| Iron and ZincZn+Fe group received 10 mg/day of elemental zinc (as zinc sulphate) and 10 mg/day of elemental iron (as ferrous sulphate) | Dietary supplement | Iron and Zinc |
| Iron, Zinc and Vitamin AZn+Fe+vit.A group received 10 mg/day of elemental zinc (as zinc sulphate) and 10 mg/day of elemental iron (as ferrous sulphate), plus 1,000 IU/day of vitamin A | Dietary supplement | Iron, Zinc and Vitamin A |
| PlaceboPlacebo group received no minerals/vitamin | Other | Placebo |
Primary outcome
Change in Length-for-Age Z-scores
Time frame: Baseline and monthly thereafter until endline (6 month of intervention)
Length-for-Age Z-score
Change in Weight-for-Length Z-scores
Time frame: Baseline and monthly thereafter until endline (6 month of intervention)
Weight-for-Length Z-score
Change in Weight-for-Age Z-scores
Time frame: Baseline and monthly thereafter until endline (6 month of intervention)
Weight-for-Age Z-scores
Changes in Mental Development Index
Time frame: Baseline and Endline (6 month of intervention)
MDI of Bayley Scale of Infant Development II
Changes in Psychomotor Development Index
Time frame: Baseline and Endline (6 month of intervention)
PDI of Bayley Scale of Infant Development II
4 secondary outcomes
Changes in Hemoglobin
Time frame: Baseline and Endline (6 month of intervention)
Changes in serum zinc
Time frame: Baseline and Endline (6 month of intervention)
Changes in serum ferritin
Time frame: Baseline and Endline (6 month of intervention)
Changes in serum retinol
Time frame: Baseline and Endline (6 month of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Background: PubMed 19094274Schultink W, Gross R. Iron deficiency alleviation in developing countries. Nutr Res Rev. 1996 Jan;9(1):281-93. doi: 10.1079/NRR19960015. No abstract available.
- Background: PubMed 2362876Colomer J, Colomer C, Gutierrez D, Jubert A, Nolasco A, Donat J, Fernandez-Delgado R, Donat F, Alvarez-Dardet C. Anaemia during pregnancy as a risk factor for infant iron deficiency: report from the Valencia Infant Anaemia Cohort (VIAC) study. Paediatr Perinat Epidemiol. 1990 Apr;4(2):196-204. doi: 10.1111/j.1365-3016.1990.tb00638.x.
- Background: PubMed 2438638Lozoff B, Brittenham GM, Wolf AW, McClish DK, Kuhnert PM, Jimenez E, Jimenez R, Mora LA, Gomez I, Krauskoph D. Iron deficiency anemia and iron therapy effects on infant developmental test performance. Pediatrics. 1987 Jun;79(6):981-95.
- Background: PubMed 7678046Idjradinata P, Pollitt E. Reversal of developmental delays in iron-deficient anaemic infants treated with iron. Lancet. 1993 Jan 2;341(8836):1-4. doi: 10.1016/0140-6736(93)92477-b.
- BackgroundBrown KH, Wuehler SE and Peerson JM (2001). The importance of zinc in human nutrition and estimation of the global prevalence of zinc deficiency. Food Nutr Bull 22 (2):113-25
- BackgroundGibson RS and Ferguson EL (1999). An Interactive 24-hour Recall for Assessing the Adequacy of Iron and Zinc Intakes in Developing Countries. ILSI Press, Washington DC
- Background: PubMed 4591425Ronaghy HA, Reinhold JG, Mahloudji M, Ghavami P, Fox MR, Halsted JA. Zinc supplementation of malnourished schoolboys in Iran: increased growth and other effects. Am J Clin Nutr. 1974 Feb;27(2):112-21. doi: 10.1093/ajcn/27.2.112. No abstract available.
- Background: PubMed 1355797Walravens PA, Chakar A, Mokni R, Denise J, Lemonnier D. Zinc supplements in breastfed infants. Lancet. 1992 Sep 19;340(8821):683-5. doi: 10.1016/0140-6736(92)92229-9.
- Background: PubMed 10885352Umeta M, West CE, Haidar J, Deurenberg P, Hautvast JG. Zinc supplementation and stunted infants in Ethiopia: a randomised controlled trial. Lancet. 2000 Jun 10;355(9220):2021-6. doi: 10.1016/S0140-6736(00)02348-5.
- Background: PubMed 8988907Rosado JL, Lopez P, Munoz E, Martinez H, Allen LH. Zinc supplementation reduced morbidity, but neither zinc nor iron supplementation affected growth or body composition of Mexican preschoolers. Am J Clin Nutr. 1997 Jan;65(1):13-9. doi: 10.1093/ajcn/65.1.13.
- Background: PubMed 8438768Cavan KR, Gibson RS, Grazioso CF, Isalgue AM, Ruz M, Solomons NW. Growth and body composition of periurban Guatemalan children in relation to zinc status: a longitudinal zinc intervention trial. Am J Clin Nutr. 1993 Mar;57(3):344-52. doi: 10.1093/ajcn/57.3.344.
- Background: PubMed 8457531Bates CJ, Evans PH, Dardenne M, Prentice A, Lunn PG, Northrop-Clewes CA, Hoare S, Cole TJ, Horan SJ, Longman SC, et al. A trial of zinc supplementation in young rural Gambian children. Br J Nutr. 1993 Jan;69(1):243-55. doi: 10.1079/bjn19930026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umi Fahmida, PhD principal investigator
South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition (SEAMEO-RECFON)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zinc Alone, Iron and Zinc and Iron, Zinc and Vitamin A in people with Development and Iron Deficiency, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Length-for-Age Z-scores (time frame: Baseline and monthly thereafter until endline (6 month of intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02319499, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014.