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The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes

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ClinicalTrials.gov Identifier: NCT06035315
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
Rima Irwinda, Dr Cipto Mangunkusumo General Hospital

Tracking Information
First Submitted Date  ICMJE September 6, 2023
First Posted Date  ICMJE September 13, 2023
Last Update Posted Date September 13, 2023
Actual Study Start Date  ICMJE May 1, 2023
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2023)
  • Maternal Outcome [ Time Frame: 1 year ]
    Maternal Death; Preterm Delivery; Preeclampsia; Intrauterine Infections; Post partum hemorrhage
  • Perinatal Outcome [ Time Frame: 1 year ]
    Neonatal death; Low birth weight; Intra uterine growth restriction; Asphyxia
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes
Official Title  ICMJE The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes
Brief Summary To monitor the effects of multi micronutrients supplementations during pregnancy towards pregnancy outcomes
Detailed Description

A randomized control trial of two clusters :

1st cluster without giving multi micronutrients; 2nd cluster giving multi micronutrients.

Differences between cluster : Additional multi micronutrients by giving : Complete multi micronutrients, calcium, vitamin D and DHA. The additional multi micronutrients were given since 1st until 3rd trimester for interventions group. There are also additional laboratory examinations for intervention group : Vitamin D, Lipid Profile and Zinc level.

In control group : we use standard public health care micronutrients (Iron supplementation and calcium); and standard blood examinations.

Ultrasound examination was performed for both cluster since 1st until 3rd trimester.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized control trial : comparison of two clusters
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Maternal Care Patterns
  • Nutrition, Healthy
  • Nutritional Deficiency
  • Maternal-Fetal Relations
  • Perinatal Outcome
  • Maternal Outcome
Intervention  ICMJE Dietary Supplement: Multiple Micronutrients during pregnancy
Pregnant women examine since 8 weeks gestation are being followed until delivery; are given additional micronutrients (Complete multi micronutrients-Calcium-Vitamin D-DHA); and perform ultrasound examinations each trimester and additional laboratory examination (Vitamin D level-Lipid profile-Zinc)
Study Arms  ICMJE
  • No Intervention: Control
    Pregnant women examine since 8 weeks gestation are being followed until delivery; are given government micronutrients; and perform ultrasound examinations each trimester and regular laboratory examination.
  • Active Comparator: Interventions
    Pregnant women examine since 8 weeks gestation are being followed until delivery; are given additional micronutrients (Complete multi micronutrients-Calcium-Vitamin D-DHA); and perform ultrasound examinations each trimester and additional laboratory examination (Vitamin D level-Lipid profile-Zinc)
    Intervention: Dietary Supplement: Multiple Micronutrients during pregnancy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 6, 2023)		 240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2024
Estimated Primary Completion Date May 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • First trimester pregnancy
  • Gestational age < 10 weeks gestation
  • Agree as research participant
  • Living in DKI Jakarta

Exclusion Criteria:

  • Assisted Reproductive
  • History of PCOS
  • History of Chronic Hypertension
  • History of Diabetes Mellitus
  • History of Preeclampsia
  • Maternal chronic disease : Cardiovascular disease; Autoimmune condition; Malignancy)
  • Plan to move from Jakarta prior or during pregnancy
  • History of Recurrent pregnancy loss
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Yurika Elizabeth, Medical Doctor +62 8999979916 yurika.elizabeth.s@gmail.com
Contact: Amanda Rumondang, Obstetrician Gynecologist +62 81318375211 amanda17.md@gmail.com
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06035315
Other Study ID Numbers  ICMJE 23-02-0259
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Rima Irwinda, Dr Cipto Mangunkusumo General Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Dr Cipto Mangunkusumo General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Dr Cipto Mangunkusumo General Hospital
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP