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StuntingNCT05100550

Family-based Health Education Program and Zinc Supplementation for Stunted Mother

A study testing Zinc in people with Stunting and Maternal-Fetal Relations, run by Hasanuddin University at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background : It is important to tackle the issue of malnutrition at an early stage. A stunted mother has a tendency of having adverse neonatal outcomes including growth restriction. The multidisciplinary intervention followed by micronutrient supplementation is developed to prevent these adverse outcomes. Read more about this study

Who is it for?
Ages 19 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Stunting, Maternal-Fetal Relations
What is being tested?
Zinc
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteIndonesia
Study dates
1 Sep 2020to 1 Dec 2021
Phase
Interventional
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 19 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Body height is less than 150 cm
  • Upper Arm Circumference less than 23.5 cm
  • Family income is less than Rp 2,500,000,- following the minimum wage of targeted area
  • 24-26 weeks pregnant.

Who cannot join

  • has pregnancy complications
  • multiple infants
  • refuse to follow the protocol

Trial locations and contacts

1 site in 1 country.

Halisah Halisah, M.Keb contact

+6285341247477

armiyatinur@gmail.com

Halisah Halisah, M.Keb contact

Indonesia1 site, 1 recruiting

  • Hasanuddin University Medical Research Center / HUMRC

    Makassar, South Sulawesi, 90245

    Bumi Herman, M.D, Ph.D, bumiherman@med.unhas.ac.id

    Bumi Herman, M.D Ph.D

    Recruiting

Other trials in Indonesia

About this study

Official title: Family-based Health Education Program and Zinc Supplementation for Stunted Mother and Its Impact on Biomarker of Growth in Baby

Background :

It is important to tackle the issue of malnutrition at an early stage. A stunted mother has a tendency of having adverse neonatal outcomes including growth restriction. The multidisciplinary intervention followed by micronutrient supplementation is developed to prevent these adverse outcomes. Zinc has been associated with better neonatal growth and brain growth. This study aims to assess the impact of family-based health education programs plus zinc supplementation on the important biomarker of pregnancy and neonatal growth.

Read more

Objective :

  1. To assess the impact of Family-based health education programs plus zinc supplementation on the outcome of pregnancy in stunted mother
  2. 1. To assess the impact of Family-based health education programs plus zinc supplementation on the outcome of neonatal growth in stunted mother

Methodology :

A Quasi-experimental study involving stunted pregnant mother with parallel intervention

Hypothesis :

Mother who receives the intervention will have the better maternal and neonatal outcome

Read the detailed description

Details of Family-Based Health Education Program + Zinc :

  1. Home-visit and health promotion by trained midwives
  2. Supervision by health volunteer
  3. Zinc Supplementation

General target population :

  1. Stunted pregnant mother on the third trimester of pregnancy
  2. Conducted in Primary Health Care Center

Design of Study :

two arms quasi-experimental study with one group receiving the intervention and comparison receiving standard Antenatal Care. The baseline measurement is conducted at the beginning of the third trimester, followed by the day of delivery and 6 months after delivery (for assessing the outcome of the infant). Participants are matched by certain variables

Variable :

  1. Sociodemographic information
  2. Food recall using Food Frequency Questionnaire

List of outcomes

  1. Zinc level in breastmilk and blood of mother and infant
  2. Insulin-like growth factor 1 (IGF-1) level of mother and infant
  3. Hemoglobin level of mother and infant
  4. Infant and placental anthropometry
  5. Tumor growth Factor Beta 1 (TGF beta 1) in infant
  6. Brain-derived neurotrophic factor (BDNF) in infant

Sample size using the difference between two means of neonatal birth weight who received zinc and did not receive zinc according to a study in Iran

  1. Type 1 error 5%
  2. Effect size: 0.4486
  3. Power of study: 80%
  4. With the equal allocation ratio, the total sample needed is 126

Proposed statistical analysis

  1. Independent T-test
  2. Linear Mixed Model
Being tested
Zinc, Control
Keywords
Insulin-like Growth Factor 1, Zinc, Hemoglobin, Health Education, Stunting, Low-income Family
Medical subject headings
Growth Disorders, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZincDietary supplement

    Zinc is given as written in the arm description, two hours after lunch

  • ControlOther

    This group will not receive zinc

Study groups in NCT05100550
Study groupRoleWhat they receive
InterventionExperimentalThis group will receive 1. Health education regarding nutrition in pregnancy (including the importance of micronutrients, recognizing malnutrition, practicing breastfeeding) 2. Screening of Low birth weight risk 3. Zinc Supplementation 20 mg/daily from gestation week for 12 weeks, followed by 12 weeks of supplementation on the third day postpartum.
Receives: Dietary Supplement: Zinc
ControlActive comparatorStandard antenatal care for third trimester will be applied without supplementation of zinc
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infant weight

    This includes weight at birth, weight at 3 months and 6 months

    Measured: changes of weight at birth up to 6 months

  2. Infant Length

    This includes length of body at birth, at 3 months and 6 months

    Measured: changes of length at birth up to 6 months

Secondary outcomes (8)

  1. Hemoglobin level of mother

    Hemoglobin level of mother measured in blood using hematology analyzer

    Measured: changes of hemoglobin level of mother from the baseline to delivery time

  2. Zinc level of mother in blood

    Zinc level of mother measured in blood using hematology analyzer

    Measured: changes of Zinc in blood of mother from the baseline to 6 months after delivery

  3. Zinc level of mother in breast milk

    Zinc level of mother measured in blood using atomic absorption spectrometric

    Measured: changes of Zinc in breast milk of mother from the delivery day to 6 months after delivery

  4. Hemoglobin level of infant

    Hemoglobin level of infant measured in blood using hematology analyzer

    Measured: changes of hemoglobin level of infant from the day of birth to 6 months

  5. Insulin-like growth factor 1 (IGF-1) of mother

    Insulin-like growth factor 1 (IGF-1) of mother measured in blood using Human IGF-1 enzyme-linked Immunosorbent Assay (ELISA)

    Measured: changes of IGF-1 level of mother from the baseline to day of delivery

  6. Insulin-like growth factor 1 (IGF-1) of infant

    Insulin-like growth factor 1 (IGF-1) of infant measured in blood using Human IGF-1 enzyme-linked Immunosorbent Assay (ELISA)

    Measured: changes of IGF-1 level of infant from the day of birth to 6 months

  7. Brain-derived neurotrophic Factor (BDNF) of infant

    Brain-derived neurotrophic Factor (BDNF) of infant measured in blood using enzyme-linked Immunosorbent Assay (ELISA)

    Measured: changes of BDNF level of infant from the day of birth to 6 months

  8. Tumor Growth Factor Beta 1 (TGF beta 1) of infant

    Tumor Growth Factor Beta 1 (TGF beta 1) of infant measured in blood using enzyme-linked Immunosorbent Assay (ELISA)

    Measured: changes of TGF Beta 1 level of infant from the day of birth to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2021
  2. Study start1 Sep 2020
  3. Primary completion15 Nov 2021 (estimated)
  4. Study completion1 Dec 2021 (estimated)

Resources

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 N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
One group is assigned for health education intervention and zinc supplementation, and the comparison group receives only standard antenatal care.
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05100550
Sponsor's protocol ID
2209210954
Status last verified
Oct 2021
First submitted
20 Oct 2021
Last updated
29 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Deidentified data will be shared accordingly

Publications

  • Boskabadi H, Maamouri G, Akhondian J, Ashrafzadeh F, Boskabadi A, Faramarzi R, Heidar E, Pourbadakhshan N, Shojaei SRH, Zakerihamidi M, Vatanchi AM, Sokhtanloo M, Razaghi N, Kalani F, Ataei H, Darabi A, Mousavi MS, Hakimiakhangan S, Bagheri F. Comparison of birth weights of neonates of mothers receiving vs. not receiving zinc supplement at pregnancy. BMC Pregnancy Childbirth. 2021 Mar 6;21(1):187. doi: 10.1186/s12884-021-03598-8.

    PubMed 33676424

  • Wilson RL, Grieger JA, Bianco-Miotto T, Roberts CT. Association between Maternal Zinc Status, Dietary Zinc Intake and Pregnancy Complications: A Systematic Review. Nutrients. 2016 Oct 15;8(10):641. doi: 10.3390/nu8100641.

    PubMed 27754451

  • Prata N, Tavrow P, Upadhyay U. Women's empowerment related to pregnancy and childbirth: introduction to special issue. BMC Pregnancy Childbirth. 2017 Nov 8;17(Suppl 2):352. doi: 10.1186/s12884-017-1490-6. No abstract available.

    PubMed 29143677

  • Finch CW. Review of trace mineral requirements for preterm infants: what are the current recommendations for clinical practice? Nutr Clin Pract. 2015 Feb;30(1):44-58. doi: 10.1177/0884533614563353. Epub 2014 Dec 19.

    PubMed 25527182

  • Zahiri Sorouri Z, Sadeghi H, Pourmarzi D. The effect of zinc supplementation on pregnancy outcome: a randomized controlled trial. J Matern Fetal Neonatal Med. 2016;29(13):2194-8. doi: 10.3109/14767058.2015.1079615. Epub 2015 Sep 12.

    PubMed 26365330

Questions about this trial

What is this clinical trial studying?

A study testing Zinc in people with Stunting and Maternal-Fetal Relations, run by Hasanuddin University 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Oct 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Halisah Halisah, M.Keb (+6285341247477, armiyatinur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infant weight (time frame: changes of weight at birth up to 6 months). The study lists 2 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 NCT05100550, which also lists 5 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 29 Oct 2021.

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